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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Oximeter
510(k) Number K982728
Device Name NELLCOR PURITAN BENNETT UNIPROBE ADAPTER CABLE, UP12A, UP12B, UP12C
Applicant
NELLCOR PURITAN BENNETT, INC.
4280 HACIENDA DR.
PLEASANTON,  CA  94588 -2719
Applicant Contact SHERYLL A MATHEWS
Correspondent
NELLCOR PURITAN BENNETT, INC.
4280 HACIENDA DR.
PLEASANTON,  CA  94588 -2719
Correspondent Contact SHERYLL A MATHEWS
Regulation Number870.2700
Classification Product Code
DQA  
Date Received08/05/1998
Decision Date 12/07/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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