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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 K962098
Device Name ESOPHAGEAL INTUBATION DETECTOR
Applicant
KIRK SPECIALTY SYSTEMS
1625 CRESCENT CIR., STE. 225
CARROLLTON,  TX  75006
Applicant Contact DALE B ICKLEY
Correspondent
KIRK SPECIALTY SYSTEMS
1625 CRESCENT CIR., STE. 225
CARROLLTON,  TX  75006
Correspondent Contact DALE B ICKLEY
Regulation Number868.5730
Classification Product Code
BTR  
Date Received05/29/1996
Decision Date 10/08/1996
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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