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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name mask, gas, anesthetic
510(k) Number K854161
Device Name SUR-FIT FACE MASK
Applicant
ANESTHESIA RESPIRATORY TECHNOLOGY, INC.
P.O. BOX 68
NOBLESVILLE,  IN  46060
Applicant Contact TIMOTHY D STRUTHERS
Correspondent
ANESTHESIA RESPIRATORY TECHNOLOGY, INC.
P.O. BOX 68
NOBLESVILLE,  IN  46060
Correspondent Contact TIMOTHY D STRUTHERS
Regulation Number868.5550
Classification Product Code
BSJ  
Date Received10/11/1985
Decision Date 11/05/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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