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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dc-Defibrillator, Low-Energy, (Including Paddles)
510(k) Number K893990
Device Name P POLYMER
Applicant
Pace West
P.O. Box 297
Fairfield,  CA  94533
Applicant Contact BRENT BOWEN
Correspondent
Pace West
P.O. Box 297
Fairfield,  CA  94533
Correspondent Contact BRENT BOWEN
Regulation Number870.5300
Classification Product Code
LDD  
Date Received06/05/1989
Decision Date 10/12/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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