Device Classification Name |
lubricant, patient
|
510(k) Number |
K101522 |
Device Name |
ULTRA SEAL STERILE LUBRICATING JELLY |
Applicant |
ULTRA SEAL CORPORATION |
521 MAIN STREET |
NEW PALTZ,
NY
12561
|
|
Applicant Contact |
JAMES DAVIS |
Correspondent |
ULTRA SEAL CORPORATION |
521 MAIN STREET |
NEW PALTZ,
NY
12561
|
|
Correspondent Contact |
JAMES DAVIS |
Regulation Number | 880.6375
|
Classification Product Code |
|
Date Received | 06/02/2010 |
Decision Date | 12/23/2010 |
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
|
|
|