The following data is part of a premarket notification filed by Travenol Laboratories, S.a. with the FDA for Silicath-ag Silicone Elastomer Foley Catheter.
Device ID | K860362 |
510k Number | K860362 |
Device Name: | SILICATH-AG SILICONE ELASTOMER FOLEY CATHETER |
Classification | Collector, Urine, (and Accessories) For Indwelling Catheter |
Applicant | TRAVENOL LABORATORIES, S.A. Deerfield, IL 60015 |
Contact | Robert L Wilkinson |
Correspondent | Robert L Wilkinson TRAVENOL LABORATORIES, S.A. Deerfield, IL 60015 |
Product Code | KNX |
CFR Regulation Number | 876.5250 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-01-30 |
Decision Date | 1986-04-29 |