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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 K811997
Device Name SHARPS SAFE
Applicant
Instra-Metics, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Instra-Metics, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number880.5570
Classification Product Code
MMK  
Date Received07/14/1981
Decision Date 08/18/1981
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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