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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name laparoscope, gynecologic (and accessories)
510(k) Number K915749
Device Name SHARPE ENDOLIGATURE CARRIER
Applicant
PALADIN MEDICAL, INC.
p.o. box 560
stillwater,  MN  55082 -0560
Applicant Contact elaine duncan
Correspondent
PALADIN MEDICAL, INC.
p.o. box 560
stillwater,  MN  55082 -0560
Correspondent Contact elaine duncan
Regulation Number884.1720
Classification Product Code
HET  
Date Received12/23/1991
Decision Date 10/20/1992
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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