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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Holder, Infant Position
510(k) Number K090284
Device Name RES-Q INFANT WEDGE AND SLING
Applicant
CR ENTERPRISES, LLC.
4701 AUGUSTA DR.
FRISCO,  TX  75034 -6839
Applicant Contact CRAIG A TROOP
Correspondent
CR ENTERPRISES, LLC.
4701 AUGUSTA DR.
FRISCO,  TX  75034 -6839
Correspondent Contact CRAIG A TROOP
Regulation Number880.5680
Classification Product Code
FRP  
Date Received02/05/2009
Decision Date 06/05/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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