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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Hood, Oxygen, Infant
510(k) Number K973128
Device Name OLYMPUS NA-10J-1 ASPIRATION NEEDLE
Applicant
Olympus America, Inc.
Two Corporate Center Dr.
Melville,  NY  11747 -3157
Applicant Contact SUBHASH R PATEL
Correspondent
Olympus America, Inc.
Two Corporate Center Dr.
Melville,  NY  11747 -3157
Correspondent Contact SUBHASH R PATEL
Regulation Number868.5700
Classification Product Code
FOG  
Date Received08/21/1997
Decision Date 11/18/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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