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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 K993969
Device Name SALJET SINGLE DOSE STERILE SALINE TOPICAL SOLUTION
Applicant
Winchester Laboratories, LLC
325 N. Water St.
Batavia,  IL  60510
Applicant Contact HOWARD ROSE
Correspondent
Winchester Laboratories, LLC
325 N. Water St.
Batavia,  IL  60510
Correspondent Contact HOWARD ROSE
Classification Product Code
FRO  
Date Received11/23/1999
Decision Date 12/30/1999
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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