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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 K944680
Device Name SPLIT TOP WING NEEDLE CAP WITH OPTIONAL TUBING ANCHORS (AND APPROPRIATE RECAP DEVICE
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 Received09/22/1994
Decision Date 01/31/1995
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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