The following data is part of a premarket notification filed by Vision Care Devices, Inc. with the FDA for Bayers Bimanual I/a Handpieces.
| Device ID | K971064 |
| 510k Number | K971064 |
| Device Name: | BAYERS BIMANUAL I/A HANDPIECES |
| Classification | Unit, Phacofragmentation |
| Applicant | VISION CARE DEVICES, INC. 1246 REDWOOD BLVD. Redding, CA 96003 |
| Contact | Chet Cracchiolo |
| Correspondent | Chet Cracchiolo VISION CARE DEVICES, INC. 1246 REDWOOD BLVD. Redding, CA 96003 |
| Product Code | HQC |
| CFR Regulation Number | 886.4670 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-03-24 |
| Decision Date | 1997-06-09 |