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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Sheet, Burn
510(k) Number K853145
Device Name KENDALL CURITY BURN PAD
Applicant
The Kendal Co.
One Federal St.
Boston,  MA  02110
Applicant Contact CHRISTINE MORGIDA
Correspondent
The Kendal Co.
One Federal St.
Boston,  MA  02110
Correspondent Contact CHRISTINE MORGIDA
Regulation Number880.5180
Classification Product Code
FPY  
Date Received07/29/1985
Decision Date 08/30/1985
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
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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