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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 K190240
Device Name Tiger Sharps Containers
Applicant
International Marketing Specialists, Inc.
1278 Hwy. 461
Somerset,  KY  42503
Applicant Contact Rod Calderon
Correspondent
Irc
2950 E Lindrick Dr.
Chandler,  AZ  85249
Correspondent Contact Charles Mack
Regulation Number880.5570
Classification Product Code
MMK  
Date Received02/06/2019
Decision Date 05/31/2019
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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