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FDA 510(k) Application Details - K952535
Device Classification Name
Suture, Nonabsorbable, Synthetic, Polyethylene
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510(K) Number
K952535
Device Name
Suture, Nonabsorbable, Synthetic, Polyethylene
Applicant
ACUFEX MICROSURGICAL, INC.
130 FORBES BLVD.
MANSFIELD, MA 02048 US
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Contact
FREDERICK TOBIA
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Regulation Number
878.5000
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Classification Product Code
GAT
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More FDA Info for this Product Code
Date Received
06/01/1995
Decision Date
02/08/1996
Decision
SN - Substantially Equivalent for Some Indications
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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