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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 K885045
Device Name PHARMACLENS LOW ABRASION WOUND SPONGE/BRUSH
Applicant
Baxter Healthcare Corp
27200 N. Tourney Rd.
P.O. Box 5900
Valencia,  CA  91355
Applicant Contact T MERRICK
Correspondent
Baxter Healthcare Corp
27200 N. Tourney Rd.
P.O. Box 5900
Valencia,  CA  91355
Correspondent Contact T MERRICK
Classification Product Code
FRO  
Date Received12/05/1988
Decision Date 03/03/1989
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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