The following data is part of a premarket notification filed by Advanced Biomedical Instruments with the FDA for Co2 Laser.
Device ID | K801197 |
510k Number | K801197 |
Device Name: | CO2 LASER |
Classification | Laser, Surgical, Gynecologic |
Applicant | ADVANCED BIOMEDICAL INSTRUMENTS 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | HHR |
CFR Regulation Number | 884.4550 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1980-05-19 |
Decision Date | 1980-06-30 |