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U.S. Department of Health and Human Services

510(k) Premarket Notification
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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 Number886.5928
Classification Product Code
LPN  
Date Received10/29/2009
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
Predetermined Change
Control Plan Authorized		 No
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