The following data is part of a premarket notification filed by Autovage with the FDA for Gastric Lavage Kit.
Device ID | K823195 |
510k Number | K823195 |
Device Name: | GASTRIC LAVAGE KIT |
Classification | Tubes, Gastrointestinal (and Accessories) |
Applicant | AUTOVAGE 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 | 1982-10-26 |
Decision Date | 1982-12-03 |