The following data is part of a premarket notification filed by Applied Medical Technologies with the FDA for Gastranimal Percutaneous Replacement Gastroomy.
| Device ID | K923488 |
| 510k Number | K923488 |
| Device Name: | GASTRANIMAL PERCUTANEOUS REPLACEMENT GASTROOMY |
| Classification | Tubes, Gastrointestinal (and Accessories) |
| Applicant | APPLIED MEDICAL TECHNOLOGIES 6100 WEST CREEK RD. SUITE 25 Independence, OH 44131 |
| Contact | Donna Bressan |
| Correspondent | Donna Bressan APPLIED MEDICAL TECHNOLOGIES 6100 WEST CREEK RD. SUITE 25 Independence, OH 44131 |
| Product Code | KNT |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-07-15 |
| Decision Date | 1995-07-20 |