The following data is part of a premarket notification filed by Pa Medical Corp. with the FDA for P.a. Enteral Feeding Bag 1100.
Device ID | K853309 |
510k Number | K853309 |
Device Name: | P.A. ENTERAL FEEDING BAG 1100 |
Classification | Tubes, Gastrointestinal (and Accessories) |
Applicant | PA MEDICAL CORP. 1512 NASHVILLE HIGHWAY P.O. BOX 1286 Columbia, TN 38401 |
Contact | Bailey Vaughn |
Correspondent | Bailey Vaughn PA MEDICAL CORP. 1512 NASHVILLE HIGHWAY P.O. BOX 1286 Columbia, TN 38401 |
Product Code | KNT |
CFR Regulation Number | 876.5980 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-08-07 |
Decision Date | 1985-08-27 |