The following data is part of a premarket notification filed by Surgitek with the FDA for Grasping Forceps.
Device ID | K922542 |
510k Number | K922542 |
Device Name: | GRASPING FORCEPS |
Classification | Dislodger, Stone, Flexible |
Applicant | SURGITEK 3037 MT. PLEASANT ST. Racine, WI 53404 |
Contact | Brian Kunst |
Correspondent | Brian Kunst SURGITEK 3037 MT. PLEASANT ST. Racine, WI 53404 |
Product Code | FGO |
CFR Regulation Number | 876.4680 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-05-29 |
Decision Date | 1992-08-19 |