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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 K000654
Device Name VBMAX
Applicant
A-M SYSTEMS, INC.
131 BUSINESS PARK LOOP
P.O. BOX 850
CARLSBORG,  WA  98324
Applicant Contact STEVE GRASSER
Correspondent
A-M SYSTEMS, INC.
131 BUSINESS PARK LOOP
P.O. BOX 850
CARLSBORG,  WA  98324
Correspondent Contact STEVE GRASSER
Regulation Number868.5260
Classification Product Code
CAH  
Date Received02/28/2000
Decision Date 11/14/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
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