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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name tube tracheostomy and tube cuff
510(k) Number K123699
Device Name FAHL TRACHEOSTOMY TUBES (MULTIPLE)
Applicant
ANDREAS FAHL MEDIZINTECHNIK-VERTRIEB GMBH
AUGUST-HORCH-STR. 4A
KOELN,  DE 51149
Applicant Contact CLAUDIA WINTERSCHLADEN
Correspondent
ANDREAS FAHL MEDIZINTECHNIK-VERTRIEB GMBH
AUGUST-HORCH-STR. 4A
KOELN,  DE 51149
Correspondent Contact CLAUDIA WINTERSCHLADEN
Regulation Number868.5800
Classification Product Code
JOH  
Subsequent Product Codes
BTO   BTR  
Date Received12/03/2012
Decision Date 08/12/2013
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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