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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 K964055
Device Name FLEXI-SITE (E203-01)/ FLEXI-FIT (E300)
Applicant
EPIC MEDICAL EQUIPMENT SERVICES, INC.
4643 WESTGROVE
DALLAS,  TX  75248
Applicant Contact JEFFREY SECUNDA
Correspondent
EPIC MEDICAL EQUIPMENT SERVICES, INC.
4643 WESTGROVE
DALLAS,  TX  75248
Correspondent Contact JEFFREY SECUNDA
Regulation Number870.2700
Classification Product Code
DQA  
Date Received10/09/1996
Decision Date 02/21/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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