The following data is part of a premarket notification filed by Intl. Medical Marketing, Inc. with the FDA for L.t.c. Replacement Gastrostomy Tube.
Device ID | K896621 |
510k Number | K896621 |
Device Name: | L.T.C. REPLACEMENT GASTROSTOMY TUBE |
Classification | Tube Impression And Matrix |
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 | KCQ |
CFR Regulation Number | 872.6570 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-11-21 |
Decision Date | 1990-03-13 |