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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Stretcher, Wheeled
510(k) Number K955766
Device Name ADULT-PEDIATRIC TRANSPORT SYSTEM
Applicant
International Biomedical, Inc.
8508 Cross Park Dr.
Austin,  TX  78754
Applicant Contact WILLIAM P SOUTH
Correspondent
International Biomedical, Inc.
8508 Cross Park Dr.
Austin,  TX  78754
Correspondent Contact WILLIAM P SOUTH
Regulation Number880.6910
Classification Product Code
FPO  
Date Received12/20/1995
Decision Date 08/07/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized
No
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