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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 K102560
Device Name REPROCESSED PULSE OXIMETER SENSORS
Applicant
STERILMED, INC.
11400 73RD AVE. N, STE. 100
MAPLE GROVE,  MN  55369
Applicant Contact GARRETT AHLBORG
Correspondent
STERILMED, INC.
11400 73RD AVE. N, STE. 100
MAPLE GROVE,  MN  55369
Correspondent Contact GARRETT AHLBORG
Regulation Number870.2700
Classification Product Code
NLF  
Date Received09/07/2010
Decision Date 02/18/2011
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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