The following data is part of a premarket notification filed by Birtcher Medical Systems, Inc. with the FDA for Birtcher Sure Clean Instrument System.
| Device ID | K930302 |
| 510k Number | K930302 |
| Device Name: | BIRTCHER SURE CLEAN INSTRUMENT SYSTEM |
| Classification | Laryngoscope, Endoscope |
| Applicant | BIRTCHER MEDICAL SYSTEMS, INC. 4775 RIVER GREEN PKWY. Duluth, GA 30092 |
| Contact | Eileen M Anderson |
| Correspondent | Eileen M Anderson BIRTCHER MEDICAL SYSTEMS, INC. 4775 RIVER GREEN PKWY. Duluth, GA 30092 |
| Product Code | GCI |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-01-21 |
| Decision Date | 1993-10-27 |