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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 K961934
Device Name PURITAN FOAM TIP SWAB MODEL 2197
Applicant
HARDWOOD PRODUCTS CO., LP
P.O. BOX 149, 31 SCHOOL ST.
GUILFORD,  ME  04443
Applicant Contact WILLIAM M YOUNG
Correspondent
HARDWOOD PRODUCTS CO., LP
P.O. BOX 149, 31 SCHOOL ST.
GUILFORD,  ME  04443
Correspondent Contact WILLIAM M YOUNG
Regulation Number884.4530
Classification Product Code
HHT  
Date Received05/17/1996
Decision Date 07/09/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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