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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, Sterile
510(k) Number K820246
Device Name PREFILLED SPECIMEN CONTAINER
Applicant
Sage Products, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Sage Products, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number864.3250
Classification Product Code
KDT  
Date Received01/29/1982
Decision Date 02/18/1982
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Pathology
510k Review Panel Pathology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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