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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 K913870
Device Name 5MM MICROSCISSORS
Applicant
ENDOVATIONS
ROSSMOYNE INDUSTRIAL PARK
5020 RITTER ROAD, SUITE 211
MECHANICSBURG,  PA  17055
Applicant Contact JANE E PREDIX
Correspondent
ENDOVATIONS
ROSSMOYNE INDUSTRIAL PARK
5020 RITTER ROAD, SUITE 211
MECHANICSBURG,  PA  17055
Correspondent Contact JANE E PREDIX
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received08/29/1991
Decision Date 09/16/1991
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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