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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 K941389
Device Name EMPI TAPE PATCHES
Applicant
Empi
1275 Grey Fox Rd.
Arden Hills,  MN  55112
Applicant Contact STACY MATTSON
Correspondent
Empi
1275 Grey Fox Rd.
Arden Hills,  MN  55112
Correspondent Contact STACY MATTSON
Regulation Number880.5240
Classification Product Code
KGX  
Date Received03/22/1994
Decision Date 08/23/1994
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
Predetermined Change
Control Plan Authorized		 No
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