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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 K040044
Device Name HEEL SNUGGLER, MODEL 99047
Applicant
Respironics, Inc.
1001 Murry Ridge Ln.
Murrysville,  PA  15668
Applicant Contact ZITA A YURKO
Correspondent
Entela, Inc.
3033 Madison Ave., SE
Grand Rapids,  MI  49548
Correspondent Contact N.E. DEVINE
Regulation Number890.5710
Classification Product Code
MPO  
Date Received01/12/2004
Decision Date 01/27/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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