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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Neuromuscular, External Functional
510(k) Number K770987
Device Name NERVE STIMULATOR, MOLEL NO. FB-800
Applicant
OUTPUT, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
OUTPUT, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number882.5810
Classification Product Code
GZI  
Date Received05/31/1977
Decision Date 06/14/1977
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
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