The following data is part of a premarket notification filed by Intl. Medical Marketing, Inc. with the FDA for L.t.c. Enteral Bag Administration Set W/pump Set.
Device ID | K895824 |
510k Number | K895824 |
Device Name: | L.T.C. ENTERAL BAG ADMINISTRATION SET W/PUMP SET |
Classification | Tube, Feeding |
Applicant | INTL. MEDICAL MARKETING, INC. P.O. BOX 578 Ridge, NY 11961 |
Contact | Ramon Monast |
Correspondent | Ramon Monast INTL. MEDICAL MARKETING, INC. P.O. BOX 578 Ridge, NY 11961 |
Product Code | FPD |
CFR Regulation Number | 876.5980 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-09-29 |
Decision Date | 1990-03-13 |