The following data is part of a premarket notification filed by Solos Endoscopy, Inc. with the FDA for Model Gs-4700 Common Duct Stone Removing Kit.
| Device ID | K910671 |
| 510k Number | K910671 |
| Device Name: | MODEL GS-4700 COMMON DUCT STONE REMOVING KIT |
| Classification | Stents, Drains And Dilators For The Biliary Ducts |
| Applicant | SOLOS ENDOSCOPY, INC. 6191 ATLANTIC BLVD. SUITE 4 Norcross, GA 30071 |
| Contact | William F Meyer |
| Correspondent | William F Meyer SOLOS ENDOSCOPY, INC. 6191 ATLANTIC BLVD. SUITE 4 Norcross, GA 30071 |
| Product Code | FGE |
| CFR Regulation Number | 876.5010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-02-15 |
| Decision Date | 1991-05-10 |