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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Needle, Emergency Airway
510(k) Number K952401
Device Name ABELSON CRICOTHYROTOMY CANNULA
Applicant
Gilbert Surgical Instruments, Inc.
115 Harding Ave.
Bellmawr,  NJ  08030
Applicant Contact GILBERT GOLDBERG
Correspondent
Gilbert Surgical Instruments, Inc.
115 Harding Ave.
Bellmawr,  NJ  08030
Correspondent Contact GILBERT GOLDBERG
Regulation Number868.5090
Classification Product Code
BWC  
Date Received05/22/1995
Decision Date 07/11/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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