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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name apparatus, exhaust, surgical
510(k) Number K920371
Device Name HPM REPLACEMENT ULPA FILTER MODEL UF001
Applicant
HPM ENT.
p.o. box 6746
laguna niguel,  CA  92607
Applicant Contact henry p muller
Correspondent
HPM ENT.
p.o. box 6746
laguna niguel,  CA  92607
Correspodent Contact henry p muller
Regulation Number878.5070
Classification Product Code
FYD  
Date Received01/28/1992
Decision Date 08/12/1992
Decision substantially equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
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