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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Filter, Bacterial, Breathing-Circuit
510(k) Number K013200
Device Name RENMED CONTAMI-SHIELD BREATHING CIRCUIT SLEEVE, MODEL 9999/01
Applicant
Rennels Medical Corp.
P.O. Box 3626
Morganton,  NC  28680
Applicant Contact DAVID LEE
Correspondent
Rennels Medical Corp.
P.O. Box 3626
Morganton,  NC  28680
Correspondent Contact DAVID LEE
Regulation Number868.5260
Classification Product Code
CAH  
Date Received09/25/2001
Decision Date 12/14/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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