The following data is part of a premarket notification filed by Sharplan Lasers, Inc. with the FDA for Sharplan Usight 9010 Laparoscopic Ultrasound System.
| Device ID | K945796 |
| 510k Number | K945796 |
| Device Name: | SHARPLAN USIGHT 9010 LAPAROSCOPIC ULTRASOUND SYSTEM |
| Classification | Transducer, Ultrasonic, Diagnostic |
| Applicant | SHARPLAN LASERS, INC. 1 PEARL COURT Allendale, NJ 07401 |
| Contact | Doug Mead |
| Correspondent | Doug Mead SHARPLAN LASERS, INC. 1 PEARL COURT Allendale, NJ 07401 |
| Product Code | ITX |
| CFR Regulation Number | 892.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-11-28 |
| Decision Date | 1995-05-24 |