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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Applicator (Laryngo-Tracheal), Topical Anesthesia
510(k) Number K760877
Device Name MONOJECT LARYNGOTRACHEAL ANESTHESIA KIT
Applicant
Sherwood Medical Industries
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Sherwood Medical Industries
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number868.5170
Classification Product Code
CCT  
Date Received10/04/1976
Decision Date 12/09/1976
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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