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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 K925234
Device Name BEDSIDE CADDY
Applicant
Researched, Novel Medical Devices (Rn/Md)
4480 Sherman Oaks Cir.
Sherman Oaks,  CA  91403
Applicant Contact ANNABELLE D TUCKER
Correspondent
Researched, Novel Medical Devices (Rn/Md)
4480 Sherman Oaks Cir.
Sherman Oaks,  CA  91403
Correspondent Contact ANNABELLE D TUCKER
Regulation Number880.5570
Classification Product Code
FMI  
Date Received10/16/1992
Decision Date 11/19/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized
No
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