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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dressing, Wound, Occlusive
510(k) Number K850076
Device Name WOUND DRESSING MODEL ZB-6
Applicant
Thermedics, Inc.
470 Wildwood St.
P.O. Box 2697
Woburn,  MA  01888
Applicant Contact MURFITT
Correspondent
Thermedics, Inc.
470 Wildwood St.
P.O. Box 2697
Woburn,  MA  01888
Correspondent Contact MURFITT
Regulation Number878.4020
Classification Product Code
NAD  
Date Received01/09/1985
Decision Date 04/15/1985
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
Predetermined Change
Control Plan Authorized		 No
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