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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Manometer, Spinal-Fluid
510(k) Number K032432
Device Name BUSSE HOSPITAL DISPOSABLES SPINAL MANOMETER
Applicant
Busse Hospital Disposables, Inc.
P.O. Box 2156
Huntington,  CT  06484
Applicant Contact JOSEPH M AZARY
Correspondent
Busse Hospital Disposables, Inc.
P.O. Box 2156
Huntington,  CT  06484
Correspondent Contact JOSEPH M AZARY
Regulation Number880.2500
Classification Product Code
FMJ  
Date Received08/06/2003
Decision Date 08/28/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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