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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Needle, Hypodermic, Single Lumen
510(k) Number K962149
Device Name SAFETY CRADLE
Applicant
Specialized Health Products, Inc.
9721 S. Altamont Dr.
Sandy,  UT  84092
Applicant Contact WILLIAM E MCKAY
Correspondent
Specialized Health Products, Inc.
9721 S. Altamont Dr.
Sandy,  UT  84092
Correspondent Contact WILLIAM E MCKAY
Regulation Number880.5570
Classification Product Code
FMI  
Date Received06/04/1996
Decision Date 10/11/1996
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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