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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Transducer, Miniature Pressure
510(k) Number K914780
Device Name TALLEY SD.500 SKIN PRESSURE EVALUATOR
Applicant
Talley Group, Ltd.
815 Terminal Rd.
Lansing,  MI  48906
Applicant Contact VAN DYKE
Correspondent
Talley Group, Ltd.
815 Terminal Rd.
Lansing,  MI  48906
Correspondent Contact VAN DYKE
Regulation Number890.1615
Classification Product Code
IKE  
Date Received10/23/1991
Decision Date 12/19/1991
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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