The following data is part of a premarket notification filed by Applied Medical Technology, Inc. with the FDA for Amt Decompression Tubes.
| Device ID | K980145 |
| 510k Number | K980145 |
| Device Name: | AMT DECOMPRESSION TUBES |
| Classification | Tube, Gastro-enterostomy |
| Applicant | APPLIED MEDICAL TECHNOLOGY, INC. 15653 NEO PKWY. Cleveland, OH 44128 |
| Contact | Thomas W Parkinson |
| Correspondent | Thomas W Parkinson APPLIED MEDICAL TECHNOLOGY, INC. 15653 NEO PKWY. Cleveland, OH 44128 |
| Product Code | KGC |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-01-15 |
| Decision Date | 1998-04-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00842071131760 | K980145 | 000 |
| 00842071131784 | K980145 | 000 |
| 00842071131463 | K980145 | 000 |
| 00842071131807 | K980145 | 000 |
| 00842071131814 | K980145 | 000 |
| 00842071131821 | K980145 | 000 |
| 00842071131838 | K980145 | 000 |
| 00842071131845 | K980145 | 000 |
| 00842071131852 | K980145 | 000 |
| 00842071131777 | K980145 | 000 |