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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Chair, Positioning, Electric
510(k) Number K912320
Device Name BIOPHYSIOMETER POSITIONING CHAIR
Applicant
Bi-Dynamics, Inc.
C/O Hogan & Hartson
555 Thirteenth St., NW
Washington,  DC  20004
Applicant Contact PATRICIA B SHRADER
Correspondent
Bi-Dynamics, Inc.
C/O Hogan & Hartson
555 Thirteenth St., NW
Washington,  DC  20004
Correspondent Contact PATRICIA B SHRADER
Regulation Number890.3110
Classification Product Code
INO  
Date Received05/24/1991
Decision Date 08/22/1991
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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