The following data is part of a premarket notification filed by Mentor O & O, Inc. with the FDA for Mentor(r) Durastat(tm) Autoclav Bipolar Hemostat.
| Device ID | K903878 |
| 510k Number | K903878 |
| Device Name: | MENTOR(R) DURASTAT(TM) AUTOCLAV BIPOLAR HEMOSTAT |
| Classification | Apparatus, Cautery, Radiofrequency, Battery-powered |
| 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 | HQQ |
| CFR Regulation Number | 886.4100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-08-22 |
| Decision Date | 1990-11-05 |