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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name light, surgical, fiberoptic
510(k) Number K071218
Device Name PROXENON 350, MODEL 902XX
Applicant
WELCH ALLYN, INC.
4341 STATE STREET ROAD
PO BOX 220
SKANEATELES FALLS,  NY  13153 -0220
Applicant Contact JOHN E SAWYER
Correspondent
WELCH ALLYN, INC.
4341 STATE STREET ROAD
PO BOX 220
SKANEATELES FALLS,  NY  13153 -0220
Correspondent Contact JOHN E SAWYER
Regulation Number878.4580
Classification Product Code
FST  
Date Received05/02/2007
Decision Date 06/14/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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