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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 K820261
Device Name MONITOR CO2 LASER SYSTEM
Applicant
Cooper Medical Corp.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Cooper Medical Corp.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number884.4550
Classification Product Code
HHR  
Date Received02/02/1982
Decision Date 03/05/1982
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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