The following data is part of a premarket notification filed by Thomasville Medical Assoc. with the FDA for Lung Retractors: Davidson, Semb.
Device ID | K930316 |
510k Number | K930316 |
Device Name: | LUNG RETRACTORS: DAVIDSON, SEMB |
Classification | Retractor |
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 | GAD |
CFR Regulation Number | 878.4800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-01-22 |
Decision Date | 1994-02-10 |