The following data is part of a premarket notification filed by Scientific Sales Intl., Inc. with the FDA for Air Uterine Displacer-aud 120.
| Device ID | K833022 |
| 510k Number | K833022 |
| Device Name: | AIR UTERINE DISPLACER-AUD 120 |
| Classification | Support, Patient Position |
| Applicant | SCIENTIFIC SALES INTL., INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | CCX |
| CFR Regulation Number | 868.6820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-09-06 |
| Decision Date | 1983-10-14 |