The following data is part of a premarket notification filed by Applied Medical Technology, Inc. with the FDA for Amt Enteral Transition Adapters.
| Device ID | K150034 |
| 510k Number | K150034 |
| Device Name: | AMT Enteral Transition Adapters |
| Classification | Enteral Specific Transition Connectors |
| Applicant | APPLIED MEDICAL TECHNOLOGY, INC. 8006 KATHERINE BOULEVARD Brecksville, OH 44141 |
| Contact | Joshua Meinke |
| Correspondent | Joshua Meinke APPLIED MEDICAL TECHNOLOGY, INC. 8006 KATHERINE BOULEVARD Brecksville, OH 44141 |
| Product Code | PIO |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-01-09 |
| Decision Date | 2015-06-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00842071109110 | K150034 | 000 |
| 00842071133313 | K150034 | 000 |
| 00842071133320 | K150034 | 000 |
| 00842071133337 | K150034 | 000 |
| 00842071133344 | K150034 | 000 |
| 00842071133351 | K150034 | 000 |
| 00842071109059 | K150034 | 000 |
| 00842071109066 | K150034 | 000 |
| 00842071109073 | K150034 | 000 |
| 00842071109080 | K150034 | 000 |
| 00842071109097 | K150034 | 000 |
| 00842071133306 | K150034 | 000 |