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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ventilator, Emergency, Manual (Resuscitator)
510(k) Number K972139
Device Name ASPR-CARE CLOSED SYSTEM,DUAL SWIVEL PIECE T,SHEATHED SUCTION CATHETER,BRONCHOSOPE ADAPTER,IN-LINE SPECIMEN TRAP
Applicant
Davis & Geck, Inc.
444 Mc Donnell Blvd.
Hazlewood,  MO  63042
Applicant Contact STEPHEN J TAMSETT
Correspondent
Davis & Geck, Inc.
444 Mc Donnell Blvd.
Hazlewood,  MO  63042
Correspondent Contact STEPHEN J TAMSETT
Regulation Number868.5915
Classification Product Code
BTM  
Date Received06/06/1997
Decision Date 09/03/1997
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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