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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 K870046
Device Name DOUBLE PUNCTURE CO2 LASER LAPAROSCOPY SET
Applicant
TTI MEDICAL
3470 MT. DIABLO BLVD.
SUITE A 150
LAFAYETTE,  CA  94549
Applicant Contact ALLEN R HOWES
Correspondent
TTI MEDICAL
3470 MT. DIABLO BLVD.
SUITE A 150
LAFAYETTE,  CA  94549
Correspondent Contact ALLEN R HOWES
Regulation Number884.4550
Classification Product Code
HHR  
Date Received01/05/1987
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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