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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Muscle, Powered
510(k) Number K932610
Device Name PCI 4000
Applicant
Pci
23041 Stearn Cir.
Lake Forest,  CA  92630
Applicant Contact HOWARD M HOLSTIEN
Correspondent
Pci
23041 Stearn Cir.
Lake Forest,  CA  92630
Correspondent Contact HOWARD M HOLSTIEN
Regulation Number890.5850
Classification Product Code
IPF  
Date Received05/28/1993
Decision Date 08/19/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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