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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Handpiece, Air-Powered, Dental
510(k) Number K052700
Device Name PANA-SPRAY
Applicant
NSK AMERICA CORP.
700-B COOPER CT.
SCHAUMBURG,  IL  60173
Applicant Contact HIROHIKO MURASE
Correspondent
NSK AMERICA CORP.
700-B COOPER CT.
SCHAUMBURG,  IL  60173
Correspondent Contact HIROHIKO MURASE
Regulation Number872.4200
Classification Product Code
EFB  
Date Received09/28/2005
Decision Date 12/20/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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