FDA 510(k) Application Details - K931769

Device Classification Name Blade, Saw, General & Plastic Surgery, Surgical

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510(K) Number K931769
Device Name Blade, Saw, General & Plastic Surgery, Surgical
Applicant SURGIQUIP, INC.
3106 LAFAYETTE AVE.
AUSTIN, TX US
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Contact MARY BIGGERS
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Regulation Number 878.4820

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Classification Product Code GFA
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Date Received 04/09/1993
Decision Date 01/27/1994
Decision SE - Substantially Equivalent
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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