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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 K884651
Device Name ELECTRO NEUROMUSCULAR STIMULATOR MODEL 2000
Applicant
Biomedical Life Systems, Inc.
1285 Stone Dr. #103
P.O. Box 128
San Marcos,  CA  92069
Applicant Contact RICHARD G SAXON
Correspondent
Biomedical Life Systems, Inc.
1285 Stone Dr. #103
P.O. Box 128
San Marcos,  CA  92069
Correspondent Contact RICHARD G SAXON
Regulation Number890.5850
Classification Product Code
IPF  
Date Received11/07/1988
Decision Date 11/06/1989
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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