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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laser, Surgical, Gynecologic
510(k) Number K801197
Device Name CO2 LASER
Applicant
ADVANCED BIOMEDICAL INSTRUMENTS
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
ADVANCED BIOMEDICAL INSTRUMENTS
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number884.4550
Classification Product Code
HHR  
Date Received05/19/1980
Decision Date 06/30/1980
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
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