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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, Occlusive
510(k) Number K905519
Device Name MONTROSE DRESSING APPLICATORS
Applicant
Olemunda Pty , Ltd.
One Landmark N.
20399 Route 19
Evans City,  PA  16033
Applicant Contact HANIA CLEVA
Correspondent
Olemunda Pty , Ltd.
One Landmark N.
20399 Route 19
Evans City,  PA  16033
Correspondent Contact HANIA CLEVA
Regulation Number878.4020
Classification Product Code
NAD  
Date Received12/07/1990
Decision Date 03/06/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
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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