The following data is part of a premarket notification filed by Sharplan Lasers, Inc. with the FDA for Sharplan Ultra Laparoscopic Handpiece.
| Device ID | K960040 |
| 510k Number | K960040 |
| Device Name: | SHARPLAN ULTRA LAPAROSCOPIC HANDPIECE |
| Classification | Instrument, Ultrasonic Surgical |
| Applicant | SHARPLAN LASERS, INC. 1 PEARL COURT Allendale, NJ 07401 |
| Contact | George J Hattub |
| Correspondent | George J Hattub SHARPLAN LASERS, INC. 1 PEARL COURT Allendale, NJ 07401 |
| Product Code | LFL |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-01-02 |
| Decision Date | 1996-04-29 |
| Summary: | summary |