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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 K941428
Device Name EXACTA PERCUTANEOUS INTRODUCER SHEATH
Applicant
Ohmeda Medical
1911 Williams Dr.
Oxnard,  CA  93030
Applicant Contact CHERYL L SHEA
Correspondent
Ohmeda Medical
1911 Williams Dr.
Oxnard,  CA  93030
Correspondent Contact CHERYL L SHEA
Regulation Number870.1340
Classification Product Code
DYB  
Date Received03/24/1994
Decision Date 07/06/1994
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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