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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pack, Hot Or Cold, Disposable
510(k) Number K934673
Device Name KACEY DISPOSABLE INFANT HEEL WARMER
Applicant
K & C Medical, Inc.
P.O. Box 52
Southport,  CT  06490
Applicant Contact ROBERT KILCULLEN
Correspondent
K & C Medical, Inc.
P.O. Box 52
Southport,  CT  06490
Correspondent Contact ROBERT KILCULLEN
Regulation Number890.5710
Classification Product Code
IMD  
Date Received09/30/1993
Decision Date 02/02/1994
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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