Device Classification Name |
Lubricant, Patient
|
510(k) Number |
K092488 |
Device Name |
DYNAREX STERILE LUBRICATING JELLY |
Applicant |
DYNAREX CORPORATION |
10 GLENSHAW ST. |
ORANGEBURG,
NY
10962
|
|
Applicant Contact |
DANIEL CONSAGA |
Correspondent |
DYNAREX CORPORATION |
10 GLENSHAW ST. |
ORANGEBURG,
NY
10962
|
|
Correspondent Contact |
DANIEL CONSAGA |
Regulation Number | 880.6375
|
Classification Product Code |
|
Date Received | 08/13/2009 |
Decision Date | 12/18/2009 |
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
|
Recalls |
CDRH Recalls
|
|
|