The following data is part of a premarket notification filed by Sharplan Lasers, Inc. with the FDA for Sharplan Model 1050 Sealed-off Co2 Surgical Laser.
Device ID | K890287 |
510k Number | K890287 |
Device Name: | SHARPLAN MODEL 1050 SEALED-OFF CO2 SURGICAL LASER |
Classification | Powered Laser Surgical Instrument |
Applicant | SHARPLAN LASERS, INC. 1 PEARL COURT Allendale, NJ 07401 |
Contact | Kenneth Raichman |
Correspondent | Kenneth Raichman SHARPLAN LASERS, INC. 1 PEARL COURT Allendale, NJ 07401 |
Product Code | GEX |
CFR Regulation Number | 878.4810 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-01-19 |
Decision Date | 1989-04-12 |