The following data is part of a premarket notification filed by Sharplan Lasers, Inc. with the FDA for Modified Sharplan Model 1020 Co2 Laser.
Device ID | K882180 |
510k Number | K882180 |
Device Name: | MODIFIED SHARPLAN MODEL 1020 CO2 LASER |
Classification | Powered Laser Surgical Instrument |
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 | GEX |
CFR Regulation Number | 878.4810 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-05-03 |
Decision Date | 1988-06-02 |