The following data is part of a premarket notification filed by Applied Urology, Inc. with the FDA for Disposable Aspiration Irrigation System.
| Device ID | K912093 |
| 510k Number | K912093 |
| Device Name: | DISPOSABLE ASPIRATION IRRIGATION SYSTEM |
| Classification | Laparoscope, Gynecologic (and Accessories) |
| Applicant | APPLIED UROLOGY, INC. 26051 MERIT CIRCLE, BLDG. 104 Laguna Hills, CA 92653 |
| Contact | Jo Stegwell |
| Correspondent | Jo Stegwell APPLIED UROLOGY, INC. 26051 MERIT CIRCLE, BLDG. 104 Laguna Hills, CA 92653 |
| Product Code | HET |
| CFR Regulation Number | 884.1720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-05-14 |
| Decision Date | 1992-04-24 |