The following data is part of a premarket notification filed by Woodbine Optical Corp. with the FDA for Solos 10mm Operating Laparoscope.
| Device ID | K970917 |
| 510k Number | K970917 |
| Device Name: | SOLOS 10MM OPERATING LAPAROSCOPE |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | WOODBINE OPTICAL CORP. 41 BROOKS DR. Braintree, MA 02184 |
| Contact | John M Ahern |
| Correspondent | John M Ahern 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 | 1997-03-12 |
| Decision Date | 1997-06-10 |