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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Oximeter, Reprocessed
510(k) Number K092368
Device Name REPROCESSED PULSE OXIMETER SENSORS
Applicant
STERILMED, INC.
11400 73RD AVE. NORTH
MAPLE GROVE,  MN  55369
Applicant Contact GARRETT AHLBORG
Correspondent
STERILMED, INC.
11400 73RD AVE. NORTH
MAPLE GROVE,  MN  55369
Correspondent Contact GARRETT AHLBORG
Regulation Number870.2700
Classification Product Code
NLF  
Date Received08/05/2009
Decision Date 11/03/2009
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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