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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
Applicant Contact DENICE GALLAGHER
Correspondent
Nurse Assist, Inc.
1415 Halsey Way, Suite 304
Carrollton,  TX  75007
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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