510(k) K203305

Tiger Reusable Sharps Container by International Marketing Specialists, Inc. — Product Code MMK

K203305 is an FDA 510(k) premarket notification submitted by International Marketing Specialists, Inc. for the device "Tiger Reusable Sharps Container". The FDA issued a decision of Substantially Equivalent on August 6, 2021. The device falls under product code MMK (Container, Sharps), a Class II device regulated under 21 CFR 880.5570. International Marketing Specialists, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 6, 2021
Date Received
November 9, 2020
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