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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 K924707
Device Name VARIOUS ANESTHETIC KITS OR TRAYS
Applicant
SPECIALTY MEDICAL PRODUCTS CO.
55 NORTHERN BLVD.
SUITE 301
GREAT NECK,  NY  11021
Applicant Contact CAROLAN KOTULA-COOK
Correspondent
SPECIALTY MEDICAL PRODUCTS CO.
55 NORTHERN BLVD.
SUITE 301
GREAT NECK,  NY  11021
Correspondent Contact CAROLAN KOTULA-COOK
Regulation Number868.5140
Classification Product Code
CAZ  
Date Received09/18/1992
Decision Date 06/17/1993
Decision Substantially Equivalent - Kit With Drugs (SEKD)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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