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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laparoscope, General & Plastic Surgery
510(k) Number K926223
Device Name ENDOSCOPE AND ACCESSORIES
Applicant
WECK ENDOSCOPY
P.O. BOX 12600 WECK DR.
RESEARCH TRIANGLE PARK,  NC  27709
Applicant Contact JOSEPH MERTIS
Correspondent
WECK ENDOSCOPY
P.O. BOX 12600 WECK DR.
RESEARCH TRIANGLE PARK,  NC  27709
Correspondent Contact JOSEPH MERTIS
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received12/10/1992
Decision Date 04/20/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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