Device Classification Name |
Scraper, Tongue
|
510(k) Number |
K990344 |
Device Name |
ORALGIENE TONGUE CLEANER |
Applicant |
ORALGIENE USA, INC. |
8460 HIGUERA ST. |
CULVER CITY,
CA
90232
|
|
Applicant Contact |
BILL MUCKLEROY |
Correspondent |
ORALGIENE USA, INC. |
8460 HIGUERA ST. |
CULVER CITY,
CA
90232
|
|
Correspondent Contact |
BILL MUCKLEROY |
Regulation Number | 872.6855
|
Classification Product Code |
|
Date Received | 02/04/1999 |
Decision Date | 05/04/1999 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|