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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 K950680
Device Name INFANT HEEL WARMER
Applicant
Baxter Healthcare Corp
1500 Waukegan Rd.
Bldg. K
Mcgaw Park,  IL  60085
Applicant Contact NICOLE M CLARK
Correspondent
Baxter Healthcare Corp
1500 Waukegan Rd.
Bldg. K
Mcgaw Park,  IL  60085
Correspondent Contact NICOLE M CLARK
Regulation Number890.5710
Classification Product Code
IMD  
Date Received02/14/1995
Decision Date 08/23/1995
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
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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