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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Spatula, Cervical, Cytological
510(k) Number K870398
Device Name PAP-PAK CYTOBRUSH KIT
Applicant
Medical Packaging Corp.
14610 Lanark St.
Panorama City,  CA  91402
Applicant Contact FREDERIC L NASON
Correspondent
Medical Packaging Corp.
14610 Lanark St.
Panorama City,  CA  91402
Correspondent Contact FREDERIC L NASON
Regulation Number884.4530
Classification Product Code
HHT  
Date Received02/02/1987
Decision Date 02/25/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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