The following data is part of a premarket notification filed by Thomasville Medical Assoc. with the FDA for Atraumatic Tenacula.
Device ID | K930037 |
510k Number | K930037 |
Device Name: | ATRAUMATIC TENACULA |
Classification | Tenaculum, Uterine |
Applicant | THOMASVILLE MEDICAL ASSOC. 935 COBBLESTONE COURT Alpharetta, GA 30201 |
Contact | Thomas J Zinnanti |
Correspondent | Thomas J Zinnanti THOMASVILLE MEDICAL ASSOC. 935 COBBLESTONE COURT Alpharetta, GA 30201 |
Product Code | HDC |
CFR Regulation Number | 884.4530 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-01-05 |
Decision Date | 1994-02-24 |