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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 K000669
FOIA Releasable 510(k) K000669
Device Name MEDIVISION I-VIEW PERSONAL VIDEO DISPLAY
Applicant
MEDIVISION ENDOSCOPY
1440 S. STATE COLLEGE BLDV.
#1D
ANAHEIM,  CA  92806
Applicant Contact WAYNE B STERNER
Correspondent
MEDIVISION ENDOSCOPY
1440 S. STATE COLLEGE BLDV.
#1D
ANAHEIM,  CA  92806
Correspondent Contact WAYNE B STERNER
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received02/28/2000
Decision Date 05/26/2000
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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