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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dressing, Wound, Drug
510(k) Number K123910
Device Name WOUNDWASH SALINE SPRAY
Applicant
Neilmed Pharmaceuticals, Inc.
601 Aviation Blvd.
Santa Rosa,  CA  95403
Applicant Contact KETAN MEHTA
Correspondent
Neilmed Pharmaceuticals, Inc.
601 Aviation Blvd.
Santa Rosa,  CA  95403
Correspondent Contact KETAN MEHTA
Classification Product Code
FRO  
Date Received12/19/2012
Decision Date 10/29/2013
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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