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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Needle, Hypodermic, Single Lumen
510(k) Number K970547
Device Name ISOLYSER SDS SHARPS CONTAINER
Applicant
THANTEX SPECIALTIES, INC.
4320 INTERNATIONAL BLVD, NW
NORCROSS,  GA  30093
Applicant Contact TOM BONNER
Correspondent
THANTEX SPECIALTIES, INC.
4320 INTERNATIONAL BLVD, NW
NORCROSS,  GA  30093
Correspondent Contact TOM BONNER
Regulation Number880.5570
Classification Product Code
FMI  
Date Received02/12/1997
Decision Date 07/18/1997
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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