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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Introducer, Catheter
510(k) Number K823262
Device Name MODEL SP5800 #8 FRENCH INTRO. KIT
Applicant
Gould, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Gould, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number870.1340
Classification Product Code
DYB  
Date Received11/02/1982
Decision Date 01/18/1983
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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