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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 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
Classification Product Code
MGQ  
Date Received11/27/1991
Decision Date 05/28/1992
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
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