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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 K920548
Device Name SHARPE ENDOSCALPEL
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 Received02/06/1992
Decision Date 09/22/1992
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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