Device Classification Name |
unit, ultraviolet sanitation/sterilization (for toothbrushes), sterile
|
510(k) Number |
K021258 |
Device Name |
GERM TERMINATOR GT 100 TOOTHBRUSH SANITIZER |
Applicant |
GERM TERMINATOR CORPORATION |
100 MAIN STREET, |
SUITE 120 |
CONCORD,
MA
01742
|
|
Applicant Contact |
DAVID LINK |
Correspondent |
INTERTEK TESTING SERVICES |
2307 EAST AURORA ROAD |
UNIT B7 |
TWINSBURG,
OH
44087
|
|
Correspondent Contact |
DONALD J SHERRATT |
Regulation Number | 872.6855
|
Classification Product Code |
|
Date Received | 04/19/2002 |
Decision Date | 05/10/2002 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|