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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
Recalls CDRH Recalls
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