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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 And Burn, Hydrogel W/Drug And/Or Biologic
510(k) Number K991755
Device Name MEDLINE TENDER WET WOUND DRESSING
Applicant
Medline Industries, Inc.
One Medline Pl.
Mundelein,  IL  60060
Applicant Contact LARA N SIMMONS
Correspondent
Medline Industries, Inc.
One Medline Pl.
Mundelein,  IL  60060
Correspondent Contact LARA N SIMMONS
Classification Product Code
MGQ  
Date Received05/24/1999
Decision Date 04/17/2000
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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