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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Biopsy, Endomyocardial
510(k) Number K890453
Device Name REUSABLE MLYOCARDIAL BIOPSY FORCEPS (BIOPTOMES
Applicant
Dlp, Inc.
620 Watson SW
P.O. Box 409
Grand Rapids,  MI  49501
Applicant Contact VAN HOF
Correspondent
Dlp, Inc.
620 Watson SW
P.O. Box 409
Grand Rapids,  MI  49501
Correspondent Contact VAN HOF
Regulation Number870.4075
Classification Product Code
DWZ  
Date Received01/30/1989
Decision Date 03/31/1989
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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