The following data is part of a premarket notification filed by Prescott's, Inc. with the FDA for Microscope Knob Cover, Sterile, Disposable.
| Device ID | K891001 |
| 510k Number | K891001 |
| Device Name: | MICROSCOPE KNOB COVER, STERILE, DISPOSABLE |
| Classification | Microscope, Operating & Accessories, Ac-powered, Ophthalmic |
| Applicant | PRESCOTT'S, INC. 2915 VANDENBURG AVE. Monument, CO 80132 |
| Contact | Paul Redner |
| Correspondent | Paul Redner PRESCOTT'S, INC. 2915 VANDENBURG AVE. Monument, CO 80132 |
| Product Code | HRM |
| CFR Regulation Number | 878.4700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-02-27 |
| Decision Date | 1989-04-11 |