The following data is part of a premarket notification filed by Sharplan Lasers, Inc. with the FDA for Co2 Rigid Laser Endoscope Probe Series 792/laparo.
| Device ID | K881010 |
| 510k Number | K881010 |
| Device Name: | CO2 RIGID LASER ENDOSCOPE PROBE SERIES 792/LAPARO |
| Classification | Laparoscope, Gynecologic (and Accessories) |
| Applicant | SHARPLAN LASERS, INC. 1 PEARL COURT Allendale, NJ 07401 |
| Contact | Stephen Dalton |
| Correspondent | Stephen Dalton SHARPLAN LASERS, INC. 1 PEARL COURT Allendale, NJ 07401 |
| Product Code | HET |
| CFR Regulation Number | 884.1720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-03-10 |
| Decision Date | 1988-04-21 |