The following data is part of a premarket notification filed by Applied Medical Technologies with the FDA for Amt Balloon Stoma Measuring Devices, Amt Balloon Measuring Device, Amt Balloon Measuring Device With Stop Valve, Amy Bae.
| Device ID | K973893 |
| 510k Number | K973893 |
| Device Name: | AMT BALLOON STOMA MEASURING DEVICES, AMT BALLOON MEASURING DEVICE, AMT BALLOON MEASURING DEVICE WITH STOP VALVE, AMY BAE |
| Classification | Tubes, Gastrointestinal (and Accessories) |
| Applicant | APPLIED MEDICAL TECHNOLOGIES 15653 NEO PKWY. Cleveland, OH 44128 -3150 |
| Contact | Thomas W Parkinson |
| Correspondent | Thomas W Parkinson APPLIED MEDICAL TECHNOLOGIES 15653 NEO PKWY. Cleveland, OH 44128 -3150 |
| Product Code | KNT |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-10-14 |
| Decision Date | 1997-12-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00842071106836 | K973893 | 000 |
| 00842071106829 | K973893 | 000 |