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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 (W/Wo Connector)
510(k) Number K843785
Device Name WISSS PEDIATRIC TRACH- TUBE W/OBTURATOR
Applicant
INTL. MEDICAL DEVICES LTD.
19205 PARTHENIA
SUITE J
NORTHRIDGE,  CA  91324 -
Applicant Contact MARCIA WEISS
Correspondent
INTL. MEDICAL DEVICES LTD.
19205 PARTHENIA
SUITE J
NORTHRIDGE,  CA  91324 -
Correspondent Contact MARCIA WEISS
Regulation Number868.5800
Classification Product Code
BTO  
Date Received09/27/1984
Decision Date 10/23/1984
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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