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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Wheelchair, Powered
510(k) Number K852381
Device Name FALCON (POWERED WHEELCHAIR)
Applicant
Venturego, Inc.
710 Fifth Ave.
Suite 3000
Pittsburg,  PA  15219
Applicant Contact ADAM N POLLOCK
Correspondent
Venturego, Inc.
710 Fifth Ave.
Suite 3000
Pittsburg,  PA  15219
Correspondent Contact ADAM N POLLOCK
Regulation Number890.3860
Classification Product Code
ITI  
Date Received06/05/1985
Decision Date 10/07/1985
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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