The following data is part of a premarket notification filed by Thomasville Medical Assoc. with the FDA for Walther Catheters, Male, Female.
Device ID | K926369 |
510k Number | K926369 |
Device Name: | WALTHER CATHETERS, MALE, FEMALE |
Classification | Catheter, Urethral |
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 | GBM |
CFR Regulation Number | 876.5130 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-12-22 |
Decision Date | 1993-05-21 |