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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tube, Tracheal (W/Wo Connector)
510(k) Number K932561
Device Name GUEDEL AIRWAYS
Applicant
LIFE SHIELD HEALTHCARE PRODUCTS, INC.
15381 STONY CREEK WAY
NOBLESVILLE,  IN  46060
Applicant Contact TIMOTHY STRUTHERS
Correspondent
LIFE SHIELD HEALTHCARE PRODUCTS, INC.
15381 STONY CREEK WAY
NOBLESVILLE,  IN  46060
Correspondent Contact TIMOTHY STRUTHERS
Regulation Number868.5730
Classification Product Code
BTR  
Date Received05/27/1993
Decision Date 07/22/1993
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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