The following data is part of a premarket notification filed by Annex Medical, Inc. with the FDA for Grasping Forceps Or Retrieval Forceps.
Device ID | K925267 |
510k Number | K925267 |
Device Name: | GRASPING FORCEPS OR RETRIEVAL FORCEPS |
Classification | Laparoscope, General & Plastic Surgery |
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 | GCJ |
CFR Regulation Number | 876.1500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-10-19 |
Decision Date | 1993-02-10 |