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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Sleeve, Limb, Compressible
510(k) Number K924891
Device Name PLEXUS PULSER I, PLEXUS PULSER II
Applicant
Dobre, Inc.
2685 Culver Ave.
Kettering,  OH  45429
Applicant Contact ROMAN SZPUR
Correspondent
Dobre, Inc.
2685 Culver Ave.
Kettering,  OH  45429
Correspondent Contact ROMAN SZPUR
Regulation Number870.5800
Classification Product Code
JOW  
Date Received09/28/1992
Decision Date 06/07/1993
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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