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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene
510(k) Number K031948
Device Name PERIPATCH SHEET, MODELS 1.5P8, 4P4, 4P6, 6P8, 10P16, 1.5P16
Applicant
Pm Devices, Inc.
2135-13700 Mayfield Pl.
Richmond, Bc,  CA V6V 2E4
Applicant Contact BRITTA DOMBOVARI
Correspondent
Pm Devices, Inc.
2135-13700 Mayfield Pl.
Richmond, Bc,  CA V6V 2E4
Correspondent Contact BRITTA DOMBOVARI
Regulation Number870.3470
Classification Product Code
DXZ  
Date Received06/24/2003
Decision Date 09/16/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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