The following data is part of a premarket notification filed by Surgeon Surgical Instrumentation, Inc. with the FDA for Sterile Eye Packs Or Trays.
Device ID | K852229 |
510k Number | K852229 |
Device Name: | STERILE EYE PACKS OR TRAYS |
Classification | 510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products 510(k) Premarket Notification Var MP = { Version: '1.0.22', Domains: {'es':'esp.fda.gov'}, SrcLang: 'en', UrlLang: 'mp_js_current_la |
Applicant | SURGEON SURGICAL INSTRUMENTATION, INC. 1061 N. SHEPARD ST. SUITE C Anaheim, CA 92806 |
Contact | Ruth Crook |
Correspondent | Ruth Crook SURGEON SURGICAL INSTRUMENTATION, INC. 1061 N. SHEPARD ST. SUITE C Anaheim, CA 92806 |
Product Code | 510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & |
CFR Regulation Number | 510(k) Premarket Notification [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-05-22 |
Decision Date | 1985-06-07 |