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FDA 510(k) Application Details - K030031
Device Classification Name
Retention Device, Suture
More FDA Info for this Device
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
Other 510(k) Applications for this Contact
Regulation Number
878.4930
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Classification Product Code
KGS
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More FDA Info for this Product Code
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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