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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
Predetermined Change
Control Plan Authorized		 No
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