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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name device, patient transfer, powered
510(k) Number K121929
Device Name ZEPHYR 'X-SERIES PATIENT TRANSFER SLED
Applicant
DIACOR, INC.
2550 decker lake blvd.
suite 26
west valley city,  UT  84119
Applicant Contact kevin anderson
Correspondent
DIACOR, INC.
2550 decker lake blvd.
suite 26
west valley city,  UT  84119
Correspondent Contact kevin anderson
Regulation Number880.6775
Classification Product Code
FRZ  
Subsequent Product Codes
IYE   LHN   LNH  
Date Received07/02/2012
Decision Date 01/17/2013
Decision substantially equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel Radiology
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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