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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 K921015
Device Name SHARPE ENDOSPONGE ASPIIRATOR
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 Received03/03/1992
Decision Date 05/21/1993
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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