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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 K964271
Device Name IGN 500 TM WATER CLEANING UNIT WITH CALBENIUM LIQUID
Applicant
Airel-West
2550 M St., NW
6th Floor
Washington,  DC  20037
Applicant Contact DANIEL A KRACOV
Correspondent
Airel-West
2550 M St., NW
6th Floor
Washington,  DC  20037
Correspondent Contact DANIEL A KRACOV
Regulation Number872.6640
Classification Product Code
EIA  
Date Received10/25/1996
Decision Date 12/19/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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