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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 K030271
Device Name VENTLAB BACTERIAL FILTER, MODEL BF100
Applicant
VENTLAB CORP.
2934 HWY. 601 NORTH
MOCKSVILLE,  NC  27028
Applicant Contact ROBERT M KELLY
Correspondent
VENTLAB CORP.
2934 HWY. 601 NORTH
MOCKSVILLE,  NC  27028
Correspondent Contact ROBERT M KELLY
Regulation Number868.5260
Classification Product Code
CAH  
Date Received01/27/2003
Decision Date 07/07/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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