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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 K082330
Device Name PRIMARY CARE SOLUTIONS, INC., STERILE WATER AND SALINE FOR IRRIGATION
Applicant
Primary Care Solutions, Inc.
40420 Free Fall Ave.
Zephyrhills,  FL  33542
Applicant Contact RON MADDIX
Correspondent
Primary Care Solutions, Inc.
40420 Free Fall Ave.
Zephyrhills,  FL  33542
Correspondent Contact RON MADDIX
Classification Product Code
FRO  
Subsequent Product Codes
FQH   JOL  
Date Received08/14/2008
Decision Date 10/09/2008
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
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