The following data is part of a premarket notification filed by American Edwards Laboratories with the FDA for Amer. Edwards Lab Flexiscope Obturator.
| Device ID | K842323 |
| 510k Number | K842323 |
| Device Name: | AMER. EDWARDS LAB FLEXISCOPE OBTURATOR |
| Classification | Arthroscope |
| Applicant | AMERICAN EDWARDS LABORATORIES 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | HRX |
| CFR Regulation Number | 888.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-06-13 |
| Decision Date | 1984-08-17 |