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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheters, Suction, Tracheobronchial
510(k) Number K892529
Device Name REPRO-MED NEONATE ASPIRATION SYSTEM
Applicant
Repro-Med Systems, Inc.
P.O. Box 191
713 N. St.
Middletown,  NY  10940
Applicant Contact ANDREW SEALFON
Correspondent
Repro-Med Systems, Inc.
P.O. Box 191
713 N. St.
Middletown,  NY  10940
Correspondent Contact ANDREW SEALFON
Regulation Number868.6810
Classification Product Code
BSY  
Date Received04/11/1989
Decision Date 06/12/1989
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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