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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name wound dressing kit
510(k) Number K970721
Device Name DYNA-FLEX MULTI-LAYER COMPRESSION SYSTEM
Applicant
JOHNSON & JOHNSON MEDICAL, INC.
2500 E. ARBROOK BLVD.
P.O. BOX 90130
ARLINGTON,  TX  76004 -3130
Applicant Contact WILLIAM P ROBB
Correspondent
JOHNSON & JOHNSON MEDICAL, INC.
2500 E. ARBROOK BLVD.
P.O. BOX 90130
ARLINGTON,  TX  76004 -3130
Correspondent Contact WILLIAM P ROBB
Regulation Number880.5075
Classification Product Code
MCY  
Date Received02/27/1997
Decision Date 03/21/1997
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
Regulation Medical Specialty General Hospital
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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