The following data is part of a premarket notification filed by Intl. Medical Marketing, Inc. with the FDA for L.t.c. Percutaneous Endoscopic Gastrostomy Tube.
Device ID | K897181 |
510k Number | K897181 |
Device Name: | L.T.C. PERCUTANEOUS ENDOSCOPIC GASTROSTOMY TUBE |
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 - With Drug (SESD) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-12-28 |
Decision Date | 1990-03-27 |