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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 K894755
Device Name ASTRA DISPOSABLE SPRAY CANNULA
Applicant
Astra Pharmaceutical Products, Inc.
50 Otis St.
Westborough,  MA  01581
Applicant Contact DAVID J PIZZI
Correspondent
Astra Pharmaceutical Products, Inc.
50 Otis St.
Westborough,  MA  01581
Correspondent Contact DAVID J PIZZI
Regulation Number868.5170
Classification Product Code
CCT  
Date Received07/27/1989
Decision Date 01/12/1990
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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