The following data is part of a premarket notification filed by Travenol Laboratories, S.a. with the FDA for Improved Silicath Silicone Elastomer.
| Device ID | K832165 |
| 510k Number | K832165 |
| Device Name: | IMPROVED SILICATH SILICONE ELASTOMER |
| Classification | Catheter, Urological |
| Applicant | TRAVENOL LABORATORIES, S.A. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | KOD |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-07-05 |
| Decision Date | 1983-08-08 |