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FDA 510(k) Application Details - K173922
Device Classification Name
Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene
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510(K) Number
K173922
Device Name
Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene
Applicant
CP Medical Inc.
1775 Corporate Dr.
Suite 150
Norcross, GA 30093 US
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Contact
John Hartigan
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Regulation Number
878.5035
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Classification Product Code
NBY
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More FDA Info for this Product Code
Date Received
12/26/2017
Decision Date
03/26/2018
Decision
SESE - SUBST EQUIV
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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