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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name laser, ent microsurgical carbon-dioxide
510(k) Number K843514
Device Name MINUTEMAN CO2 MICROSURGICAL LASER OTO
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 Number874.4500
Classification Product Code
EWG  
Date Received09/05/1984
Decision Date 12/04/1984
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Type Traditional
Reviewed by Third Party No
Combination Product No
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