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 |