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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name stimulator, muscle, powered, dental
510(k) Number K203525
Device Name D function
Applicant
ITO CO., LTD.
3-1-8 Sakae-cho
Kawaguchi-shi,  JP 332-0017
Applicant Contact Takeshi Kobayashi
Correspondent
ITO CO., LTD.
3-1-8 Sakae-cho
Kawaguchi-shi,  JP 332-0017
Correspondent Contact Takeshi Kobayashi
Regulation Number890.5850
Classification Product Code
NUW  
Date Received12/01/2020
Decision Date 05/05/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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