The following data is part of a premarket notification filed by Storz Instrument Co. with the FDA for Storz Super Sorb Micro Eye Sponge.
Device ID | K800082 |
510k Number | K800082 |
Device Name: | STORZ SUPER SORB MICRO EYE SPONGE |
Classification | Gauze/sponge, Internal |
Applicant | STORZ INSTRUMENT CO. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | EFQ |
CFR Regulation Number | 510(k) Premarket Notification [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1980-01-14 |
Decision Date | 1980-02-05 |