The following data is part of a premarket notification filed by Sharplan Lasers, Inc. with the FDA for Sharplan Model Ultra Ultrasonic Surg Aspirator.
| Device ID | K913848 |
| 510k Number | K913848 |
| Device Name: | SHARPLAN MODEL ULTRA ULTRASONIC SURG ASPIRATOR |
| Classification | Aspirator, Ultrasonic |
| Applicant | SHARPLAN LASERS, INC. 1 PEARL COURT Allendale, NJ 07401 |
| Contact | Douglass Mead |
| Correspondent | Douglass Mead SHARPLAN LASERS, INC. 1 PEARL COURT Allendale, NJ 07401 |
| Product Code | MGI |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-08-27 |
| Decision Date | 1992-03-27 |