The following data is part of a premarket notification filed by Applied Medical Technologies with the FDA for Pre-loaded Replacement G-tubes And Accessories.
| Device ID | K972478 |
| 510k Number | K972478 |
| Device Name: | PRE-LOADED REPLACEMENT G-TUBES AND ACCESSORIES |
| Classification | Tubes, Gastrointestinal (and Accessories) |
| Applicant | APPLIED MEDICAL TECHNOLOGIES 6551 BRECKSVILLE RD. Independence, OH 44131 |
| Contact | Thomas W Parkinson |
| Correspondent | Thomas W Parkinson APPLIED MEDICAL TECHNOLOGIES 6551 BRECKSVILLE RD. 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 | 1997-07-01 |
| Decision Date | 1998-02-09 |