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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 K943662
Device Name LAPARASCOPE
Applicant
POLLUX ENDOSCOPY, INC.
4696 N.W. 103RD AVE.
SUNRISE,  FL  33351
Correspondent
POLLUX ENDOSCOPY, INC.
4696 N.W. 103RD AVE.
SUNRISE,  FL  33351
Regulation Number884.1720
Classification Product Code
HET  
Date Received07/28/1994
Decision Date 05/25/1995
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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