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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name camera, cine, endoscopic, without audio
510(k) Number K883760
Device Name STORZ MODEL 62 ENT CAMERA SYSTEM
Applicant
STORZ INSTRUMENT CO.
3365 TREE CT. INDUSTRIAL BLVD.
ST. LOUIS,  MO  63122 -6694
Applicant Contact DAN REGAN
Correspondent
STORZ INSTRUMENT CO.
3365 TREE CT. INDUSTRIAL BLVD.
ST. LOUIS,  MO  63122 -6694
Correspondent Contact DAN REGAN
Regulation Number878.4160
Classification Product Code
FWL  
Date Received09/06/1988
Decision Date 09/28/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
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