The following data is part of a premarket notification filed by Solos Endoscopy, Inc. with the FDA for Gs-1300 Atraumatic Grasping Forcep, Curved, 10mm.
Device ID | K900958 |
510k Number | K900958 |
Device Name: | GS-1300 ATRAUMATIC GRASPING FORCEP, CURVED, 10MM |
Classification | Carrier, Ligature |
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 | GEJ |
CFR Regulation Number | 878.4800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-02-27 |
Decision Date | 1990-04-18 |