510(k) K131630

PURITAN AMIES MEDIUM COLLECTION AND TRANSPORT SYSTEM by Puritan Medical Products, LLC — Product Code LIO

K131630 is an FDA 510(k) premarket notification submitted by Puritan Medical Products, LLC for the device "PURITAN AMIES MEDIUM COLLECTION AND TRANSPORT SYSTEM". The FDA issued a decision of Substantially Equivalent on October 21, 2013. The device falls under product code LIO (Device, Specimen Collection), a Class I device regulated under 21 CFR 866.2900. Puritan Medical Products, LLC has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 21, 2013
Date Received
June 4, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Specimen Collection
Device Class
Class I
Regulation Number
866.2900
Review Panel
MI
Submission Type