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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 K884397
Device Name PHARMASEAL STERILE WOUND CARE DRESSING
Applicant
Baxter Healthcare Corp
27200 N. Tourney Rd.
P.O. Box 5900
Valencia,  CA  91355
Applicant Contact W GETLIN
Correspondent
Baxter Healthcare Corp
27200 N. Tourney Rd.
P.O. Box 5900
Valencia,  CA  91355
Correspondent Contact W GETLIN
Classification Product Code
FRO  
Date Received10/19/1988
Decision Date 12/27/1988
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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