The following data is part of a premarket notification filed by B&b Medical Assoc., Inc. with the FDA for Vac (oscillating Vitrector).
| Device ID | K881520 |
| 510k Number | K881520 |
| Device Name: | VAC (OSCILLATING VITRECTOR) |
| Classification | Instrument, Vitreous Aspiration And Cutting, Ac-powered |
| Applicant | B&B MEDICAL ASSOC., INC. 4 CANAL ST. Danvers, MA 01923 |
| Contact | Alden C Bertrand |
| Correspondent | Alden C Bertrand B&B MEDICAL ASSOC., INC. 4 CANAL ST. Danvers, MA 01923 |
| Product Code | HQE |
| CFR Regulation Number | 886.4150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-04-11 |
| Decision Date | 1988-09-07 |