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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name transducer, ultrasonic, obstetric
510(k) Number K827885
Device Name BIO-DERM COUPLING LOTION
Applicant
WHS PRODUCTS, INC.
3312B SOUTH PEORIA
TULSA,  OK  74105
Correspondent
WHS PRODUCTS, INC.
3312B SOUTH PEORIA
TULSA,  OK  74105
Regulation Number884.2960
Classification Product Code
HGL  
Date Received01/01/1982
Decision Date 01/29/1982
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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