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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, Hydrogel Without Drug And/Or Biologic
510(k) Number K915359
Device Name PROMEON HYDROGEL DRESSING #45 STERILE W/ MESH
Applicant
Medtronic Vascular
6700 Shingle Creek Pky
Brooklyn Center,  MN  55430
Applicant Contact DAVID MUELLER
Correspondent
Medtronic Vascular
6700 Shingle Creek Pky
Brooklyn Center,  MN  55430
Correspondent Contact DAVID MUELLER
Regulation Number878.4022
Classification Product Code
NAE  
Date Received11/27/1991
Decision Date 05/28/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
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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