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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Unit, Operative Dental
510(k) Number K950175
Device Name THE AQUA-AIR PROFESSIONAL FIELD UNIT(S)
Applicant
Aqua-Air Medical Devices, Inc.
3275 NW 28th St.
Miami,  FL  33142
Applicant Contact PHILIP M HALL
Correspondent
Aqua-Air Medical Devices, Inc.
3275 NW 28th St.
Miami,  FL  33142
Correspondent Contact PHILIP M HALL
Regulation Number872.6640
Classification Product Code
EIA  
Date Received01/17/1995
Decision Date 04/18/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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