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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 K945874
Device Name EUROMEDICAL POLY TRACHEOTOMY TUBE
Applicant
REGULATORY & MARKETING SERVICES, INC.
P.O. BOX 2308
1247 FLORIDA AVENUE
PALM HARBOR,  FL  34682 -2308
Applicant Contact PATRICK J LAMB
Correspondent
REGULATORY & MARKETING SERVICES, INC.
P.O. BOX 2308
1247 FLORIDA AVENUE
PALM HARBOR,  FL  34682 -2308
Correspondent Contact PATRICK J LAMB
Regulation Number868.5800
Classification Product Code
JOH  
Date Received12/01/1994
Decision Date 12/27/1994
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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