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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 Ave.
Palm Harbor,  FL  34682
Applicant Contact PATRICK J LAMB
Correspondent
Regulatory & Marketing Services, Inc.
P.O. Box 2308
1247 Florida Ave.
Palm Harbor,  FL  34682
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
Predetermined Change
Control Plan Authorized		 No
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