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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tube, Tracheal (W/Wo Connector)
510(k) Number K880487
Device Name NEOTECH MECONIUM ASPIRATOR (STERILE)
Applicant
Neotech Products, Inc.
9135 Alabama Ave., Suite F
Chatsworth,  CA  91311
Applicant Contact THOMAS R THORNBURY
Correspondent
Neotech Products, Inc.
9135 Alabama Ave., Suite F
Chatsworth,  CA  91311
Correspondent Contact THOMAS R THORNBURY
Regulation Number868.5730
Classification Product Code
BTR  
Date Received02/04/1988
Decision Date 05/06/1988
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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