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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 K203305
Device Name Tiger Reusable Sharps Container
Applicant
International Marketing Specialists Inc.
1278 HWY 461
Somerset,  KY  42503
Applicant Contact Rod Calderon
Correspondent
IRC
2950 E Lindrick Drive
Chandler,  AZ  85249
Correspondent Contact Charles Mack
Regulation Number880.5570
Classification Product Code
MMK  
Date Received11/09/2020
Decision Date 08/06/2021
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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