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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue
510(k) Number K041890
Device Name CRYOCOR MODEL 1250 (BREVA) SERIES SURGICAL PROBES, MODEL 1255-15-12
Applicant
Cryocor, Inc.
9717 Pacific Heights Blvd.
San Diego,  CA  92121
Applicant Contact JAMI MILLER
Correspondent
Cryocor, Inc.
9717 Pacific Heights Blvd.
San Diego,  CA  92121
Correspondent Contact JAMI MILLER
Regulation Number878.4400
Classification Product Code
OCL  
Date Received07/12/2004
Decision Date 09/22/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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