The following data is part of a premarket notification filed by Corpak Co. with the FDA for Corpak Farrell Valve Enteral Gastric Pressure Reli.
Device ID | K853253 |
510k Number | K853253 |
Device Name: | CORPAK FARRELL VALVE ENTERAL GASTRIC PRESSURE RELI |
Classification | Tubes, Gastrointestinal (and Accessories) |
Applicant | CORPAK CO. 100 CHADDICK DR. Wheeling, IL 60090 |
Contact | Edwards |
Correspondent | Edwards CORPAK CO. 100 CHADDICK DR. Wheeling, IL 60090 |
Product Code | KNT |
CFR Regulation Number | 876.5980 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-08-02 |
Decision Date | 1985-11-05 |