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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Aid, Transfer
510(k) Number K780935
Device Name GRAB BAR
Applicant
Orthopedic Equipment Co., Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Orthopedic Equipment Co., Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number890.5050
Classification Product Code
IKX  
Date Received06/07/1978
Decision Date 06/19/1978
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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