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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 K901078
Device Name SINGLE-USE, STERILE 4OZ BOTTLE CONTAIN 0.9% SALINE
Applicant
L H M ENT., INC.
855 VIRGINIA AVENUE,
P.O. BOX 431
PALM HARBOR,  FL  34683
Applicant Contact PAT LAMB
Correspondent
L H M ENT., INC.
855 VIRGINIA AVENUE,
P.O. BOX 431
PALM HARBOR,  FL  34683
Correspondent Contact PAT LAMB
Regulation Number868.5800
Classification Product Code
BTO  
Date Received03/07/1990
Decision Date 05/18/1990
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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