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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bandage, Cast
510(k) Number K873111
Device Name CONFORMA(TM) PLASTER BANDAGES
Applicant
The Kendal Co.
One Federal St.
Boston,  MA  02110
Applicant Contact CYNTHIA A ZAHOUR
Correspondent
The Kendal Co.
One Federal St.
Boston,  MA  02110
Correspondent Contact CYNTHIA A ZAHOUR
Regulation Number890.3025
Classification Product Code
ITG  
Date Received08/10/1987
Decision Date 10/09/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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