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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Anesthesia Conduction Kit
510(k) Number K994059
Device Name CLA KIT (CONTINUOUS LOCAL ANESTHESIA), MODEL 551-17, 551-10, 551-07
Applicant
Hdc Corp.
2109 O'Toole Ave.
San Jose,  CA  95131
Applicant Contact JAMES ABILLA
Correspondent
Hdc Corp.
2109 O'Toole Ave.
San Jose,  CA  95131
Correspondent Contact JAMES ABILLA
Regulation Number868.5140
Classification Product Code
CAZ  
Date Received11/29/1999
Decision Date 10/13/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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