The following data is part of a premarket notification filed by Akron Catheter, Inc. with the FDA for Catheter, Natural Latex Urethral.
Device ID | K760440 |
510k Number | K760440 |
Device Name: | CATHETER, NATURAL LATEX URETHRAL |
Classification | Catheter, Urological |
Applicant | AKRON CATHETER, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | KOD |
CFR Regulation Number | 876.5130 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1976-08-16 |
Decision Date | 1976-10-20 |