The following data is part of a premarket notification filed by Birtcher Medical Systems, Inc. with the FDA for Solos Fan Retractors.
| Device ID | K925824 |
| 510k Number | K925824 |
| Device Name: | SOLOS FAN RETRACTORS |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | BIRTCHER MEDICAL SYSTEMS, INC. 50 TECHNOLOGY DR. Irvine, CA 92718 |
| Contact | Gustavus D Bock |
| Correspondent | Gustavus D Bock BIRTCHER MEDICAL SYSTEMS, INC. 50 TECHNOLOGY DR. Irvine, CA 92718 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-11-17 |
| Decision Date | 1993-03-01 |