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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 K920710
Device Name AIR MEDICA III
Applicant
Hinatawada Seimitsu Mfg. Co., Ltd.
1101 Capital Of Texas Hgwy, S.
Austin,  TX  78746
Applicant Contact WESTER, JR
Correspondent
Hinatawada Seimitsu Mfg. Co., Ltd.
1101 Capital Of Texas Hgwy, S.
Austin,  TX  78746
Correspondent Contact WESTER, JR
Regulation Number872.6640
Classification Product Code
EIA  
Date Received02/18/1992
Decision Date 05/04/1992
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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