FDA 510(k) Application Details - K124033

Device Classification Name Scalpel, Ultrasonic, Reprocessed

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510(K) Number K124033
Device Name Scalpel, Ultrasonic, Reprocessed
Applicant SURGICAL INSTRUMENTS SERVICE AND SAVINGS, INC.
2747 SW 6TH STREET
REDMOND, OR 97756 US
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Contact BRANDI J PANTELEON
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Regulation Number 000.0000

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Classification Product Code NLQ
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Date Received 12/28/2012
Decision Date 01/07/2014
Decision SESE - SUBST EQUIV
Classification Advisory Committee -
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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