The following data is part of a premarket notification filed by Woodbine Optical Corp. with the FDA for Woodbine/solos, High Resolution 3-chip Surgical Camera.
| Device ID | K953086 |
| 510k Number | K953086 |
| Device Name: | WOODBINE/SOLOS, HIGH RESOLUTION 3-CHIP SURGICAL CAMERA |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | WOODBINE OPTICAL CORP. 41 BROOKS DR. Braintree, MA 02184 |
| Contact | Robert H Segersten |
| Correspondent | Robert H Segersten 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 | 1995-07-03 |
| Decision Date | 1995-09-22 |