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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Table, Physical Therapy, Multi Function
510(k) Number K895343
Device Name PRENATAL WEDGE
Applicant
Kay Ent.
7701 E. Pima
Tucson,  AZ  85715
Applicant Contact JOHN JACOBS
Correspondent
Kay Ent.
7701 E. Pima
Tucson,  AZ  85715
Correspondent Contact JOHN JACOBS
Regulation Number890.5880
Classification Product Code
JFB  
Date Received09/01/1989
Decision Date 09/29/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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