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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Chair, Adjustable, Mechanical
510(k) Number K923095
Device Name KAYE MODEL KIAO PELVIC/THIGH STABILIZER
Applicant
Kaye Products, Inc.
535 Dimmocks Mill Rd.
Hillsborough,  NC  27278
Applicant Contact H, BAGSHAWE
Correspondent
Kaye Products, Inc.
535 Dimmocks Mill Rd.
Hillsborough,  NC  27278
Correspondent Contact H, BAGSHAWE
Regulation Number890.3100
Classification Product Code
INN  
Date Received06/25/1992
Decision Date 07/21/1992
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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