The following data is part of a premarket notification filed by American Hospital Supply Corp. with the FDA for Nelaton Catheter.
Device ID | K792038 |
510k Number | K792038 |
Device Name: | NELATON CATHETER |
Classification | Catheter, Urological |
Applicant | AMERICAN HOSPITAL SUPPLY CORP. 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 | 1979-10-12 |
Decision Date | 1979-11-13 |