The following data is part of a premarket notification filed by Thomasville Medical Assoc. with the FDA for Micro Surgery Needle Holders.
Device ID | K930110 |
510k Number | K930110 |
Device Name: | MICRO SURGERY NEEDLE HOLDERS |
Classification | Instrument, Manual, Specialized Obstetric-gynecologic |
Applicant | THOMASVILLE MEDICAL ASSOC. 1100-B CAMBRIDGE SQUARE Alpharetta, GA 30201 |
Contact | Thomasd J Zinnanti |
Correspondent | Thomasd J Zinnanti THOMASVILLE MEDICAL ASSOC. 1100-B CAMBRIDGE SQUARE Alpharetta, GA 30201 |
Product Code | KNA |
CFR Regulation Number | 884.4530 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-01-11 |
Decision Date | 1994-02-24 |