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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 K864378
Device Name CO2 LASER MICROMANIPULATOR
Applicant
TRANSAMERICAN TECHNOLOGIES INTL.
3470 MT. DIABLO BOULEVARD,
SUITE A150
LAFAYETTE,  CA  94549
Applicant Contact ALLEN R HOWES
Correspondent
TRANSAMERICAN TECHNOLOGIES INTL.
3470 MT. DIABLO BOULEVARD,
SUITE A150
LAFAYETTE,  CA  94549
Correspondent Contact ALLEN R HOWES
Regulation Number884.4550
Classification Product Code
HHR  
Date Received11/05/1986
Decision Date 03/05/1987
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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