The following data is part of a premarket notification filed by Woodbine Optical Corp. with the FDA for Solos, Cideo Camera Replacement Cable, 800/900 Series.
| Device ID | K970056 |
| 510k Number | K970056 |
| Device Name: | SOLOS, CIDEO CAMERA REPLACEMENT CABLE, 800/900 SERIES |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | WOODBINE OPTICAL CORP. 41 BROOKS DR. Braintree, MA 02184 |
| Contact | Paul Dias |
| Correspondent | Paul Dias WOODBINE OPTICAL CORP. 41 BROOKS DR. Braintree, MA 02184 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-01-07 |
| Decision Date | 1997-01-28 |