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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 K963053
Device Name 9000 SERIES FILTER & FILTER/HME
Applicant
Enternet Medical, Inc.
4542 E. Tropicana Ave. #100
Las Vegas,  NV  89121
Applicant Contact STEVEN GONZALES
Correspondent
Enternet Medical, Inc.
4542 E. Tropicana Ave. #100
Las Vegas,  NV  89121
Correspondent Contact STEVEN GONZALES
Regulation Number868.5260
Classification Product Code
CAH  
Date Received08/06/1996
Decision Date 02/21/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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