510(k) K161737

RELI REDIDIOX Dyed, RELI REDIDIOX, RELI REDIDIOX Undyed by Myco Medical — Product Code NEW

K161737 is an FDA 510(k) premarket notification submitted by Myco Medical for the device "RELI REDIDIOX Dyed, RELI REDIDIOX, RELI REDIDIOX Undyed". The FDA issued a decision of Substantially Equivalent on Mar 2, 2017. The device falls under product code NEW (Suture, Surgical, Absorbable, Polydioxanone), a Class II device regulated under 21 CFR 878.4840. Myco Medical has 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Mar 2, 2017
Date Received
Jun 23, 2016
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Suture, Surgical, Absorbable, Polydioxanone
Device Class
Class II
Regulation Number
878.4840
Review Panel
SU
Submission Type
510(k)