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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wire, Guide, Catheter
510(k) Number K935998
Device Name ENTERPRISE
Applicant
Camp Intl., Inc.
P.O. Box 352
Grand Rapids,  MI  49501
Applicant Contact KATHLEEN P FOCHTMAN
Correspondent
Camp Intl., Inc.
P.O. Box 352
Grand Rapids,  MI  49501
Correspondent Contact KATHLEEN P FOCHTMAN
Regulation Number870.1330
Classification Product Code
DQX  
Date Received12/15/1993
Decision Date 11/17/1995
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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