Substantial Equivalence Chart Sacks Holdings Inc. / i-Promotions Inc. / Similar Non-Clinical Performance Data Sacks Holdings Inc. / Sacks Holdings Inc. / Company Low Density Polyethylene (Product #9931) BASF Corporation / Sinopec Shanghai Petrochemical Company Limited / Various Carolina Color Corporation / BASF Corporation / Technological Characteristics Intended Use Sacks Holdings Inc / SUMMARY Sacks Holdings Inc. / Date Prepared Sacks Holdings Inc. / /
Event
FDA Phase / / /
IndustryTerm
contact lens care products / fuirther announcements concerning your device / predicate device / manufacturing practice requirements / applicants device / chemical disinfection / marketed predicate devices / lens care product / manufacturing practice / applicant device / identified predicate device / rigid gas permeable / Internet address http / /
Organization
Division of Postmarket Surveillance / Division of Ophthalmic / Neurological / and Ear / Food and Drug Administration / Center for Devices and Radiological Health / office of Compliance / office of Device Evaluation / Device Evaluation Center for Devices / International Standard Organization / Division of Small Manufacturers / International and Consumer Assistance / Division of Ophthalmic / CDRH's office of Surveillance / Ear / Nose and Throat Devices Office / /
Person
Silver Spring / Devin Chodorow / / /
Product
the applicants device are M800E Polypropylene / ISO Acute Systemic Injection / Federal Food / M800E Polypropylene / /
1C210 O30 610(k) SUMMARY Sacks Holdings, Inc. Contact Lens Storage Case