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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Specimen Collection
510(k) Number K896794
Device Name SPECIMEN CONTAINER
Applicant
Westmark, Sterile Packing Systems, Inc. (Sps)
1253 Ramona St. SE
Grand Rapids,  MI  49507
Applicant Contact SURY SHONEY
Correspondent
Westmark, Sterile Packing Systems, Inc. (Sps)
1253 Ramona St. SE
Grand Rapids,  MI  49507
Correspondent Contact SURY SHONEY
Regulation Number866.2900
Classification Product Code
LIO  
Date Received12/01/1989
Decision Date 03/01/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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