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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 K940599
Device Name DUAL AIR/WATER FILTER CARTRIDGE HANDLE KIT
Applicant
Q. C. Filter, Inc.
34 Mint Cir.
Middleburg,  FL  32068
Applicant Contact JAMES HANSEN
Correspondent
Q. C. Filter, Inc.
34 Mint Cir.
Middleburg,  FL  32068
Correspondent Contact JAMES HANSEN
Regulation Number872.6640
Classification Product Code
EIA  
Date Received02/10/1994
Decision Date 04/29/1994
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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