Device Classification Name |
syringe, piston
|
510(k) Number |
K122122 |
Device Name |
REGEN SPRAY APPLICATOR, |
Applicant |
REGEN LAB SA |
3428 AVENUE MARCIL |
MONTREAL,
CA
H4A 2Z3
|
|
Applicant Contact |
GUY FORTIER |
Correspondent |
REGEN LAB SA |
3428 AVENUE MARCIL |
MONTREAL,
CA
H4A 2Z3
|
|
Correspondent Contact |
GUY FORTIER |
Regulation Number | 880.5860
|
Classification Product Code |
|
Date Received | 07/17/2012 |
Decision Date | 11/09/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|