The following data is part of a premarket notification filed by Birtcher Medical Systems, Inc. with the FDA for Birtcher Bronchus & Lung Clamp (gs-1620 & Gs-1600).
| Device ID | K930887 |
| 510k Number | K930887 |
| Device Name: | BIRTCHER BRONCHUS & LUNG CLAMP (GS-1620 & GS-1600) |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | BIRTCHER MEDICAL SYSTEMS, INC. 50 TECHNOLOGY DR. Irvine, CA 92718 |
| Contact | Eileen M Anderson |
| Correspondent | Eileen M Anderson 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 | 1993-02-19 |
| Decision Date | 1994-04-25 |