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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Container, Specimen Mailer And Storage, Temperature Controlled, Sterile
510(k) Number K970580
Device Name SASI-DC1TS
Applicant
Substance Abuse Specialties, Inc.
P.O.Box 14587
Research Triangle Park,  NC  27709
Applicant Contact LIBBY HAMILTON
Correspondent
Substance Abuse Specialties, Inc.
P.O.Box 14587
Research Triangle Park,  NC  27709
Correspondent Contact LIBBY HAMILTON
Regulation Number864.3250
Classification Product Code
KDW  
Date Received02/14/1997
Decision Date 04/17/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Pathology
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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