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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Intravascular, Diagnostic
510(k) Number K931629
Device Name CARAPACE ANGIOGRAPHY TRAYS
Applicant
Carapace, Inc.
2701 W Concord St.
Broken Arrow,  OK  74012
Applicant Contact JERRY W MYERS
Correspondent
Carapace, Inc.
2701 W Concord St.
Broken Arrow,  OK  74012
Correspondent Contact JERRY W MYERS
Regulation Number870.1200
Classification Product Code
DQO  
Date Received04/02/1993
Decision Date 12/06/1993
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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