The following data is part of a premarket notification filed by Solos Endoscopy, Inc. with the FDA for Gs-4100 Reducer Sleeve, 5mm To 3mm.
| Device ID | K900961 |
| 510k Number | K900961 |
| Device Name: | GS-4100 REDUCER SLEEVE, 5MM TO 3MM |
| Classification | Cannula And Trocar, Suprapubic, Non-disposable |
| Applicant | SOLOS ENDOSCOPY, INC. 6191 ATLANTIC BLVD. SUITE 4 Norcross, GA 30071 |
| Contact | Leila H Holmes |
| Correspondent | Leila H Holmes SOLOS ENDOSCOPY, INC. 6191 ATLANTIC BLVD. SUITE 4 Norcross, GA 30071 |
| Product Code | FBM |
| CFR Regulation Number | 876.5090 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-02-27 |
| Decision Date | 1990-04-18 |