Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K181582
Device Classification Name
Suture, Surgical, Absorbable, Polydioxanone
More FDA Info for this Device
510(K) Number
K181582
Device Name
Suture, Surgical, Absorbable, Polydioxanone
Applicant
Demetech Corporation
14175 NW 60th Ave
Miami Lakes, FL 33014 US
Other 510(k) Applications for this Company
Contact
Linda Hernandez
Other 510(k) Applications for this Contact
Regulation Number
878.4840
More FDA Info for this Regulation Number
Classification Product Code
NEW
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
06/15/2018
Decision Date
08/27/2018
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
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact