The following data is part of a premarket notification filed by California Laboratories, Inc. with the FDA for Hexascan Handpiece For Argon/dye Laser.
Device ID | K884431 |
510k Number | K884431 |
Device Name: | HEXASCAN HANDPIECE FOR ARGON/DYE LASER |
Classification | Powered Laser Surgical Instrument |
Applicant | CALIFORNIA LABORATORIES, INC. 5964 LA PLACE COURT Carlsbad, CA 92008 -8861 |
Contact | Kenneth R Michael |
Correspondent | Kenneth R Michael CALIFORNIA LABORATORIES, INC. 5964 LA PLACE COURT Carlsbad, CA 92008 -8861 |
Product Code | GEX |
CFR Regulation Number | 878.4810 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-10-21 |
Decision Date | 1988-12-02 |