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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 K941153
Device Name EPI-SPINAL ANESTHESIA TRAY
Applicant
PREFERRED MEDICAL PRODUCTS
269 PORTAGE RD.
LEWISTON,  NY  14092
Applicant Contact JANE PARTICK
Correspondent
PREFERRED MEDICAL PRODUCTS
269 PORTAGE RD.
LEWISTON,  NY  14092
Correspondent Contact JANE PARTICK
Regulation Number868.5140
Classification Product Code
CAZ  
Date Received03/11/1994
Decision Date 05/30/1995
Decision Substantially Equivalent - Kit (SESK)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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