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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 K083042
Device Name WOUND FLUSH, STERILE WATER & NORMAL SALINE
Applicant
Nurse Assist, Inc.
1415 Halsey Way, Suite 304
Carrollton,  TX  75007 -4455
Applicant Contact DENICE GALLAGHER
Correspondent
Nurse Assist, Inc.
1415 Halsey Way, Suite 304
Carrollton,  TX  75007 -4455
Correspondent Contact DENICE GALLAGHER
Classification Product Code
FRO  
Date Received10/14/2008
Decision Date 12/18/2008
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product Yes
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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