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FDA 510(k) Application Details - K102274
Device Classification Name
Needle, Aspiration And Injection, Disposable
More FDA Info for this Device
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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More FDA Info for this Product Code
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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