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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name nebulizer (direct patient interface)
510(k) Number K873395
Device Name HOYER SOLVET
Applicant
INFRASONICS CORP.
9944 BARNES CANYON RD.
SAN DIEGO,  CA  92121
Applicant Contact JIM HITCHIN
Correspondent
INFRASONICS CORP.
9944 BARNES CANYON RD.
SAN DIEGO,  CA  92121
Correspondent Contact JIM HITCHIN
Regulation Number868.5630
Classification Product Code
CAF  
Date Received08/24/1987
Decision Date 10/20/1987
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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