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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Gown, Surgical
510(k) Number K915502
Device Name MEDLINE, GORE-TEX BARRIER, SURGICAL GOWNS & DRAPES
Applicant
Medline
One Medline Pl.
Mundelein,  IL  60060
Applicant Contact LOCK
Correspondent
Medline
One Medline Pl.
Mundelein,  IL  60060
Correspondent Contact LOCK
Regulation Number878.4040
Classification Product Code
FYA  
Date Received12/09/1991
Decision Date 04/29/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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