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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 K910811
Device Name SENSOR SHIELD
Applicant
MEDICAL TAPING SYSTEMS, INC.
13 DAN DR.
GLENMOORE,  PA  19343
Applicant Contact STEPHEN D SOLENBERG
Correspondent
MEDICAL TAPING SYSTEMS, INC.
13 DAN DR.
GLENMOORE,  PA  19343
Correspondent Contact STEPHEN D SOLENBERG
Regulation Number870.2700
Classification Product Code
DQA  
Date Received02/26/1991
Decision Date 12/23/1992
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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