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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Muscle, Powered
510(k) Number K961751
Device Name W.M.E. GPS 1001
Applicant
Weaver Medical Electronics, Inc.
145 Vivian St.
Longmont,  CO  80501
Applicant Contact BENSON C WEAVER
Correspondent
Weaver Medical Electronics, Inc.
145 Vivian St.
Longmont,  CO  80501
Correspondent Contact BENSON C WEAVER
Regulation Number890.5850
Classification Product Code
IPF  
Date Received05/06/1996
Decision Date 09/25/1997
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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