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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 K933755
Device Name SENSOR SHIELD, MODIFICATION
Applicant
MEDICAL TAPING SYSTEMS, INC.
13 DAN DR.
GLENMOORE,  PA  19343
Applicant Contact STEPHEN D SOLENBERGER
Correspondent
MEDICAL TAPING SYSTEMS, INC.
13 DAN DR.
GLENMOORE,  PA  19343
Correspondent Contact STEPHEN D SOLENBERGER
Regulation Number870.2700
Classification Product Code
DQA  
Date Received05/05/1993
Decision Date 08/16/1994
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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