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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tape, Measuring, Rulers And Calipers
510(k) Number K951064
Device Name DISPOSABLE WOUND MEASURE GUIDE, PLASTIC, PROTECTOR, WOUND, PLASTIC
Applicant
S-E Sales & Distribution, Inc.
P.O. Box 131
Poultney,  VT  05764
Applicant Contact RICHARD J FRANK
Correspondent
S-E Sales & Distribution, Inc.
P.O. Box 131
Poultney,  VT  05764
Correspondent Contact RICHARD J FRANK
Regulation Number878.4800
Classification Product Code
FTY  
Date Received03/08/1995
Decision Date 05/19/1995
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
Predetermined Change
Control Plan Authorized		 No
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