The following data is part of a premarket notification filed by Sharplan Lasers, Inc. with the FDA for Sharplan 2100,3000,sharplaser 65, 40.
Device ID | K920865 |
510k Number | K920865 |
Device Name: | SHARPLAN 2100,3000,SHARPLASER 65, 40 |
Classification | Powered Laser Surgical Instrument |
Applicant | SHARPLAN LASERS, INC. COLUMBIA SQUARE 555 THIRTEENTH STREET NW Washington, DC 20004 |
Contact | Jonathan S Kahan |
Correspondent | Jonathan S Kahan SHARPLAN LASERS, INC. COLUMBIA SQUARE 555 THIRTEENTH STREET NW Washington, DC 20004 |
Product Code | GEX |
CFR Regulation Number | 878.4810 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-02-25 |
Decision Date | 1993-08-02 |