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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 K954562
Device Name GYNETECH P.O.S. SPAP SMEAR CELL COLLECTION & TRANSPORT KIT
Applicant
Gynetech, Inc.
P. O. Box 101
Springdale,  AR  72765
Applicant Contact WILLIAM J DUNN
Correspondent
Gynetech, Inc.
P. O. Box 101
Springdale,  AR  72765
Correspondent Contact WILLIAM J DUNN
Regulation Number884.4530
Classification Product Code
HHT  
Date Received10/02/1995
Decision Date 12/22/1995
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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