The following data is part of a premarket notification filed by Mentor O & O, Inc. with the FDA for Mentor(r) Sur-e-trol(r).
| Device ID | K910637 |
| 510k Number | K910637 |
| Device Name: | MENTOR(R) SUR-E-TROL(R) |
| Classification | Pump, Infusion |
| 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 | FRN |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-02-13 |
| Decision Date | 1991-05-13 |