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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name arterial blood sampling kit
510(k) Number K950098
Device Name NEEDLE SAFETY COVER
Original Applicant
HAMMER-PLANE, INC.
4025 yuma st.
simi valley,  CA  93063
Original Contact david delaplane
Regulation Number868.1100
Classification Product Code
CBT  
Date Received01/10/1995
Decision Date 08/11/1995
Decision substantially equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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