FDA 510(k) Application Details - K030031

Device Classification Name Retention Device, Suture

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510(K) Number K030031
Device Name Retention Device, Suture
Applicant ACCU-SPEED, INCORPORATED
P.O. BOX 1008, 65 GAY RD.
GROTON, MA 01450 US
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Contact ROBERT W SECOVICH
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Regulation Number 878.4930

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Classification Product Code KGS
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Date Received 01/03/2003
Decision Date 01/28/2003
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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