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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 K800946
Device Name URINARY CATHETER SAMPLING KIT
Applicant
Sage Products, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Sage Products, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number864.3250
Classification Product Code
KDT  
Date Received04/22/1980
Decision Date 06/20/1980
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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