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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name tape and bandage, adhesive
510(k) Number K952606
Device Name TARGETT PATCH
Applicant
CUTTING EDGE TECHNOLOGIES, INC.
11 ROSELAWN LN.
MALVERN,  PA  19355
Applicant Contact GEORGE H MYERS
Correspondent
CUTTING EDGE TECHNOLOGIES, INC.
11 ROSELAWN LN.
MALVERN,  PA  19355
Correspondent Contact GEORGE H MYERS
Regulation Number880.5240
Classification Product Code
KGX  
Date Received06/06/1995
Decision Date 12/21/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
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