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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Bed, Air Fluidized
510(k) Number K924973
Device Name DYLNAMEDICS A.S.A.P.
Applicant
Dynamedics, Inc.
30 Adelaide St. N.
London, Ontario,
Canada, N6b3n5,  CA
Applicant Contact STEPHEN MATHESON
Correspondent
Dynamedics, Inc.
30 Adelaide St. N.
London, Ontario,
Canada, N6b3n5,  CA
Correspondent Contact STEPHEN MATHESON
Regulation Number890.5160
Classification Product Code
INX  
Date Received09/30/1992
Decision Date 10/15/1993
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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