The following data is part of a premarket notification filed by Primrose Medical, Inc. with the FDA for Enteral Feeding Tubes.
Device ID | K881978 |
510k Number | K881978 |
Device Name: | ENTERAL FEEDING TUBES |
Classification | Tubes, Gastrointestinal (and Accessories) |
Applicant | PRIMROSE MEDICAL, INC. 20 CABOT RD. Woburn, MA 01801 |
Contact | Fletcher Longley |
Correspondent | Fletcher Longley PRIMROSE MEDICAL, INC. 20 CABOT RD. Woburn, MA 01801 |
Product Code | KNT |
CFR Regulation Number | 876.5980 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-05-11 |
Decision Date | 1988-07-13 |