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FDA 510(k) Application Details - K062125
Device Classification Name
Suture, Nonabsorbable, Synthetic, Polypropylene
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510(K) Number
K062125
Device Name
Suture, Nonabsorbable, Synthetic, Polypropylene
Applicant
SUTURA, INC.
555 THIRTEENTH ST. NW
WASHINGTON, DC 20004 US
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Contact
GERARD J PRUD'HOMME
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Regulation Number
878.5010
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Classification Product Code
GAW
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Date Received
07/25/2006
Decision Date
10/19/2006
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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