The following data is part of a premarket notification filed by Travenol Laboratories, S.a. with the FDA for Travasorb Nasogastric Nasointestinal.
Device ID | K823082 |
510k Number | K823082 |
Device Name: | TRAVASORB NASOGASTRIC NASOINTESTINAL |
Classification | Tubes, Gastrointestinal (and Accessories) |
Applicant | TRAVENOL LABORATORIES, S.A. 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | KNT |
CFR Regulation Number | 876.5980 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1982-10-20 |
Decision Date | 1982-11-16 |