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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Chair, With Casters
510(k) Number K924848
Device Name KAYE SCOOT-ABOUT, MODEL SB1
Applicant
Kaye Products, Inc.
535 Dimmocks Mill Rd.
Hillsborough,  NC  27278
Applicant Contact LILLA H BAGSHAWE
Correspondent
Kaye Products, Inc.
535 Dimmocks Mill Rd.
Hillsborough,  NC  27278
Correspondent Contact LILLA H BAGSHAWE
Regulation Number890.3100
Classification Product Code
INM  
Date Received09/28/1992
Decision Date 02/12/1993
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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