Device Classification Name |
accessories, soft lens products
|
510(k) Number |
K093367 |
Device Name |
STERILE SALINE SOLUTION |
Applicant |
CACHET PHARMACEUTICALS PVT. LTD. |
415 SHAH NAHAR, WORLI |
MUMBAI,
IN
400 018
|
|
Applicant Contact |
SHIVKUMAR AGRAWAL |
Correspondent |
CACHET PHARMACEUTICALS PVT. LTD. |
415 SHAH NAHAR, WORLI |
MUMBAI,
IN
400 018
|
|
Correspondent Contact |
SHIVKUMAR AGRAWAL |
Regulation Number | 886.5928
|
Classification Product Code |
|
Date Received | 10/29/2009 |
Decision Date | 09/10/2010 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|