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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name mesh, surgical
510(k) Number K040835
Device Name PERIPATCH SHEET, MODELS 1.5P8, 1.5P16, 4P4, 4P6, 6P8 AND 10P16
Applicant
PM DEVICES, INC.
2135-13700 MAYFIELD PLACE
RICHMOND, BC,  CA V6V 2E4
Applicant Contact BRITTA DOMBOVARI
Correspondent
PM DEVICES, INC.
2135-13700 MAYFIELD PLACE
RICHMOND, BC,  CA V6V 2E4
Correspondent Contact BRITTA DOMBOVARI
Regulation Number878.3300
Classification Product Code
FTM  
Date Received03/31/2004
Decision Date 06/15/2004
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
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