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FDA 510(k) Application Details - K180321
Device Classification Name
Suture, Nonabsorbable, Synthetic, Polypropylene
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510(K) Number
K180321
Device Name
Suture, Nonabsorbable, Synthetic, Polypropylene
Applicant
Aesculap, Inc.
3773 Corporate Parkway
Center Valley, PA 18034 US
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Contact
Kathy A. Racosky
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Regulation Number
878.5010
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Classification Product Code
GAW
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More FDA Info for this Product Code
Date Received
02/05/2018
Decision Date
03/07/2018
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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