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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name apparatus, gas-scavenging
510(k) Number K921313
Device Name AEROSTAR
Applicant
BIOSAFETY SYSTEMS, INC.
8380 CAMINO SANTA FE
SAN DIEGO,  CA  92121
Correspondent
BIOSAFETY SYSTEMS, INC.
8380 CAMINO SANTA FE
SAN DIEGO,  CA  92121
Regulation Number868.5430
Classification Product Code
CBN  
Date Received03/18/1992
Decision Date 09/11/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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