The following data is part of a premarket notification filed by Urohealth Systems, Inc. with the FDA for Intubation Endoscope And Introducer Sheath.
| Device ID | K970107 |
| 510k Number | K970107 |
| Device Name: | INTUBATION ENDOSCOPE AND INTRODUCER SHEATH |
| Classification | Bronchoscope (flexible Or Rigid) |
| Applicant | UROHEALTH SYSTEMS, INC. 3050 REDHILL AVE. Costa Mesa, CA 92626 |
| Contact | Ronald H Bergeson |
| Correspondent | Ronald H Bergeson UROHEALTH SYSTEMS, INC. 3050 REDHILL AVE. Costa Mesa, CA 92626 |
| Product Code | EOQ |
| CFR Regulation Number | 874.4680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-01-13 |
| Decision Date | 1997-11-18 |
| Summary: | summary |