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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Infant Heel Warmer (Chemical Heat Pack)
510(k) Number K961154
Device Name BAXTER SODIUM ACETATE INFANT HEEL WARMER
Applicant
Baxter Healthcare Corp
1500 Waukegan Rd.
Bldg. K
Mcgaw Park,  IL  60085
Applicant Contact MARYALICE SMITH
Correspondent
Baxter Healthcare Corp
1500 Waukegan Rd.
Bldg. K
Mcgaw Park,  IL  60085
Correspondent Contact MARYALICE SMITH
Regulation Number890.5710
Classification Product Code
MPO  
Date Received03/22/1996
Decision Date 06/06/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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