The following data is part of a premarket notification filed by W. J. Medical Instruments, Inc. with the FDA for Stealth Surgical Irrigator Aspirator.
| Device ID | K930511 |
| 510k Number | K930511 |
| Device Name: | STEALTH SURGICAL IRRIGATOR ASPIRATOR |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | W. J. MEDICAL INSTRUMENTS, INC. 3537 OLD CONEJO RD. SUITE 109 Newbury Park, CA 91320 |
| Contact | William Zinnanti |
| Correspondent | William Zinnanti W. J. MEDICAL INSTRUMENTS, INC. 3537 OLD CONEJO RD. SUITE 109 Newbury Park, CA 91320 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-02-01 |
| Decision Date | 1993-06-25 |