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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 K984434
Device Name MEDIVISION LAPAROSCOPE
Applicant
MEDIVISION SCOPE SERVICE CENTER, INC.
1440 S. STATE COLLEGE BLVD.
#1D
ANAHEIM,  CA  92806
Applicant Contact WAYNE B STERNER
Correspondent
MEDIVISION SCOPE SERVICE CENTER, INC.
1440 S. STATE COLLEGE BLVD.
#1D
ANAHEIM,  CA  92806
Correspondent Contact WAYNE B STERNER
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received12/14/1998
Decision Date 03/17/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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