The following data is part of a premarket notification filed by Autovage with the FDA for Quicvage Plus.
Device ID | K914908 |
510k Number | K914908 |
Device Name: | QUICVAGE PLUS |
Classification | Catheter (gastric, Colonic, Etc.), Irrigation And Aspiration |
Applicant | AUTOVAGE 1631 CITATION DR. South Park, PA 15129 |
Contact | Joseph P Rudolph |
Correspondent | Joseph P Rudolph AUTOVAGE 1631 CITATION DR. South Park, PA 15129 |
Product Code | KDH |
CFR Regulation Number | 876.5980 [🔎] |
Decision | Substantially Equivalent - Kit (SESK) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-11-01 |
Decision Date | 1992-04-13 |