The following data is part of a premarket notification filed by Mentor O & O, Inc. with the FDA for Mentor(r) Wet-field(r) Ii Ac Coagulator, 22-1305.
| Device ID | K911160 |
| 510k Number | K911160 |
| Device Name: | MENTOR(R) WET-FIELD(R) II AC COAGULATOR, 22-1305 |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | MENTOR O & O, INC. 3000 LONGWATER DR. Norwell, MA 02061 -1672 |
| Contact | Richard L Follett |
| Correspondent | Richard L Follett MENTOR O & O, INC. 3000 LONGWATER DR. Norwell, MA 02061 -1672 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-03-15 |
| Decision Date | 1991-05-02 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00886158030317 | K911160 | 000 |
| 30886158011430 | K911160 | 000 |
| 30886158010655 | K911160 | 000 |
| 30886158010648 | K911160 | 000 |
| 30886158010570 | K911160 | 000 |
| 30886158010563 | K911160 | 000 |
| 30886158010549 | K911160 | 000 |
| 30886158010532 | K911160 | 000 |
| 30886158010525 | K911160 | 000 |
| 30886158010518 | K911160 | 000 |
| 30886158010501 | K911160 | 000 |
| 30886158010495 | K911160 | 000 |
| 30886158010488 | K911160 | 000 |
| 30886158010471 | K911160 | 000 |
| 30886158011447 | K911160 | 000 |
| 30886158012024 | K911160 | 000 |
| 30886158013557 | K911160 | 000 |
| 00886158030256 | K911160 | 000 |
| 00886158030171 | K911160 | 000 |
| 00886158029915 | K911160 | 000 |
| 00886158029533 | K911160 | 000 |
| 00886158025535 | K911160 | 000 |
| 30886158014967 | K911160 | 000 |
| 30886158014950 | K911160 | 000 |
| 30886158014943 | K911160 | 000 |
| 30886158014936 | K911160 | 000 |
| 30886158014929 | K911160 | 000 |
| 30886158014912 | K911160 | 000 |
| 30886158014905 | K911160 | 000 |
| 30886158014899 | K911160 | 000 |
| 30886158010464 | K911160 | 000 |