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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Vascular, For Promoting Embolization
510(k) Number K854273
Device Name SILICONE OIL 350 CNETISTOKE
Applicant
Pacific Medical Industries
3134 Bunche Ave.
San Diego,  CA  92122
Applicant Contact CHARLES W KERBER
Correspondent
Pacific Medical Industries
3134 Bunche Ave.
San Diego,  CA  92122
Correspondent Contact CHARLES W KERBER
Regulation Number870.3300
Classification Product Code
KRD  
Date Received09/20/1985
Decision Date 11/22/1985
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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