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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 K973914
Device Name SENSE TECHNOLOGY INC. FRAS, SENSE TECHNOLOGY INC. PULSTAR
Applicant
Sense Technology, Inc.
3251 Old Frankstown Rd.
Pittsburgh,  PA  15239
Correspondent
Sense Technology, Inc.
3251 Old Frankstown Rd.
Pittsburgh,  PA  15239
Classification Product Code
LXM  
Date Received10/14/1997
Decision Date 06/30/1998
Decision Substantially Equivalent (SESE)
510k Review Panel Physical Medicine
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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