Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K203525
Device Classification Name
Stimulator, Muscle, Powered, Dental
More FDA Info for this Device
510(K) Number
K203525
Device Name
Stimulator, Muscle, Powered, Dental
Applicant
ITO CO., LTD.
3-1-8 Sakae-cho
Kawaguchi-shi 332-0017 JP
Other 510(k) Applications for this Company
Contact
Takeshi Kobayashi
Other 510(k) Applications for this Contact
Regulation Number
890.5850
More FDA Info for this Regulation Number
Classification Product Code
NUW
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/01/2020
Decision Date
05/05/2021
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
PM - Physical Medicine
Review Advisory Committee
DE - Dental
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact