FDA 510(k) Application Details - K102274

Device Classification Name Needle, Aspiration And Injection, Disposable

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510(K) Number K102274
Device Name Needle, Aspiration And Injection, Disposable
Applicant ARVIK ENTERPRISES/ MINI LAP TECHNOLOGIES
80 SHELTON TECHNOLOGY CENTER
SHELTON, CT 06484 US
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Contact CURTIS RAYMOND
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Regulation Number 878.4800

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Classification Product Code GAA
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Date Received 08/11/2010
Decision Date 06/15/2011
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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