The following data is part of a premarket notification filed by Annex Medical, Inc. with the FDA for Grasping Forceps.
Device ID | K896058 |
510k Number | K896058 |
Device Name: | GRASPING FORCEPS |
Classification | Surgical Instruments, G-u, Manual (and Accessories) |
Applicant | ANNEX MEDICAL, INC. 7887 FULLER RD. #109 Eden Prairie, MN 55344 |
Contact | Stuart J Lind |
Correspondent | Stuart J Lind ANNEX MEDICAL, INC. 7887 FULLER RD. #109 Eden Prairie, MN 55344 |
Product Code | KOA |
CFR Regulation Number | 876.4730 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-10-18 |
Decision Date | 1989-12-28 |