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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name stimulator, nerve, battery-powered
510(k) Number K890746
Device Name MYOTEST DBS NERVE STIMULATOR
Applicant
BIOMETER INTL. A/S
21 A/ HANS EGEDESVEJ
DK- - 5210 ODENSE NV
DENMARK,  DK
Applicant Contact FLEMMING HIMMELSTRUP
Correspondent
BIOMETER INTL. A/S
21 A/ HANS EGEDESVEJ
DK- - 5210 ODENSE NV
DENMARK,  DK
Correspondent Contact FLEMMING HIMMELSTRUP
Regulation Number868.2775
Classification Product Code
BXN  
Date Received02/13/1989
Decision Date 07/14/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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