The following data is part of a premarket notification filed by Vision Medical, Inc. with the FDA for Microscis(tm) Introcular Scissor System.
| Device ID | K913837 |
| 510k Number | K913837 |
| Device Name: | MICROSCIS(TM) INTROCULAR SCISSOR SYSTEM |
| Classification | Instrument, Vitreous Aspiration And Cutting, Ac-powered |
| Applicant | VISION MEDICAL, INC. 820 OPTIMO AVE. Fremont, CA 94539 |
| Contact | Thomas Lo |
| Correspondent | Thomas Lo VISION MEDICAL, INC. 820 OPTIMO AVE. Fremont, CA 94539 |
| Product Code | HQE |
| CFR Regulation Number | 886.4150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-08-26 |
| Decision Date | 1991-11-05 |