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FDA 510(k) Application Details - K172149
Device Classification Name
Suture, Nonabsorbable, Silk
More FDA Info for this Device
510(K) Number
K172149
Device Name
Suture, Nonabsorbable, Silk
Applicant
M/s. Meril Endo Surgery Private Limited
Third Floor, E1-E3, Meril Park,
Survey No. 135/2/B & 174/2, Muktanand Marg
Chala, Vapi 396191 IN
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Contact
Umesh Sharma
Other 510(k) Applications for this Contact
Regulation Number
878.5030
More FDA Info for this Regulation Number
Classification Product Code
GAP
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
07/17/2017
Decision Date
10/20/2017
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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