The following data is part of a premarket notification filed by Gambro, Inc. with the FDA for Crafton Arthroscopy Pump Ap-10.
| Device ID | K823848 |
| 510k Number | K823848 |
| Device Name: | CRAFTON ARTHROSCOPY PUMP AP-10 |
| Classification | Arthroscope |
| Applicant | GAMBRO, INC. 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 | 1982-12-21 |
| Decision Date | 1983-03-08 |