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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name needle, emergency airway
510(k) Number K200190
Device Name ScalpelCric
Applicant
VBM Medizintechnik GmbH
Einsteinstrasse 1
Sulz am Neckar,  DE 72172
Applicant Contact Jannika Jaeger
Correspondent
VBM Medizintechnik GmbH
Einsteinstrasse 1
Sulz am Neckar,  DE 72172
Correspondent Contact Jannika Jaeger
Regulation Number868.5090
Classification Product Code
BWC  
Subsequent Product Code
JOH  
Date Received01/27/2020
Decision Date 10/30/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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