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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Manipulator, Plunger-Like Joint
510(k) Number K940085
Device Name FORCE RECORDING AND ANALYSIS SYSTEM, MODEL 01
Applicant
Sense Technology, Inc.
3251 Old Frankstown Rd.
Pittsburgh,  PA  15239
Applicant Contact JOSEPH M EVANS
Correspondent
Sense Technology, Inc.
3251 Old Frankstown Rd.
Pittsburgh,  PA  15239
Correspondent Contact JOSEPH M EVANS
Classification Product Code
LXM  
Date Received01/07/1994
Decision Date 12/07/1994
Decision Substantially Equivalent (SESE)
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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