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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Container, Sharps
510(k) Number K153363
Device Name Red2Green Reusable Sharps Container
Applicant
Triumvirate Environmental, Inc.
200 Inner Belt Rd.
Somerville,  MA  02143
Applicant Contact STEVE TODISCO
Correspondent
Acknowledge Regulatory Strategies
2834 Hawthorn St.
San Diego,  CA  92104
Correspondent Contact Allison C. Komiyama
Regulation Number880.5570
Classification Product Code
MMK  
Date Received11/20/2015
Decision Date 07/26/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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