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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 K843515
Device Name MINUTEMAN CO2 MICROSURGICAL LASER GYN
Applicant
American Surgical Laser, Inc.
600 W Cummings Pk
Suite 3050
Woburn,  MA  01801
Applicant Contact RICHARD W TUCKER
Correspondent
American Surgical Laser, Inc.
600 W Cummings Pk
Suite 3050
Woburn,  MA  01801
Correspondent Contact RICHARD W TUCKER
Regulation Number884.4550
Classification Product Code
HHR  
Date Received09/05/1984
Decision Date 02/04/1985
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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