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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 K951386
Device Name COMBINATION CAMERA/LIGHT SOURCE
Applicant
M.P. Video, Inc.
4 Marc Rd.
Medway,  MA  02053
Applicant Contact WINIFRED SHANNON
Correspondent
M.P. Video, Inc.
4 Marc Rd.
Medway,  MA  02053
Correspondent Contact WINIFRED SHANNON
Regulation Number876.1500
Classification Product Code
GCJ  
Subsequent Product Codes
FST   FSW  
Date Received03/27/1995
Decision Date 06/30/1995
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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