510(k) K151249

PUREWAY SHARPS COLLECTOR 1.2 GALLON, PUREWAY SHARPS COLLECTOR 2 GALLON, PUREWAY SHARPS COLLECTOR 3 GALLON by Pureway Compliance, Inc. — Product Code MMK

K151249 is an FDA 510(k) premarket notification submitted by Pureway Compliance, Inc. for the device "PUREWAY SHARPS COLLECTOR 1.2 GALLON, PUREWAY SHARPS COLLECTOR 2 GALLON, PUREWAY SHARPS COLLECTOR 3 GALLON". The FDA issued a decision of Substantially Equivalent on September 4, 2015. The device falls under product code MMK (Container, Sharps), a Class II device regulated under 21 CFR 880.5570. Pureway Compliance, Inc. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 4, 2015
Date Received
May 12, 2015
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Container, Sharps
Device Class
Class II
Regulation Number
880.5570
Review Panel
HO
Submission Type