The following data is part of a premarket notification filed by Birtcher Medical Systems, Inc. with the FDA for Gi-1090,1095,1080,1085,1086,1088, Endo. Clamps.
| Device ID | K930496 |
| 510k Number | K930496 |
| Device Name: | GI-1090,1095,1080,1085,1086,1088, ENDO. CLAMPS |
| Classification | Laryngoscope, Endoscope |
| 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 | GCI |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-02-01 |
| Decision Date | 1993-04-20 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10850048763651 | K930496 | 000 |
| 10850048763200 | K930496 | 000 |
| 10850048763217 | K930496 | 000 |
| 10850048763224 | K930496 | 000 |
| 10850048763231 | K930496 | 000 |
| 10850048763248 | K930496 | 000 |
| 10850048763255 | K930496 | 000 |
| 10850048763262 | K930496 | 000 |
| 10850048763279 | K930496 | 000 |
| 10850048763286 | K930496 | 000 |
| 10850048763309 | K930496 | 000 |
| 10850048763354 | K930496 | 000 |
| 10850048763613 | K930496 | 000 |
| 10850048763620 | K930496 | 000 |
| 10850048763637 | K930496 | 000 |
| 10850048763194 | K930496 | 000 |