The following data is part of a premarket notification filed by Applied Medical Technologies with the FDA for Cauterization Smoke Evacuator.
| Device ID | K971758 |
| 510k Number | K971758 |
| Device Name: | CAUTERIZATION SMOKE EVACUATOR |
| Classification | Electrosurgical, Cutting & Coagulation & 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 | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-05-13 |
| Decision Date | 1997-07-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00842071109943 | K971758 | 000 |
| 00842071109929 | K971758 | 000 |
| 00842071109912 | K971758 | 000 |
| 00842071109899 | K971758 | 000 |
| 00842071139377 | K971758 | 000 |
| 00842071139360 | K971758 | 000 |