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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stylet, Tracheal Tube
510(k) Number K944729
Device Name STYLET SHEATH WITH LOCKING CAP AND REUSABLE BATTERY OPERATED LIGHT SOURCE
Applicant
COAST MEDICAL, INC.
1060 NORTH BATAVIA
UNIT H
ORANGE,  CA  92667
Applicant Contact TIM L TRUITT
Correspondent
COAST MEDICAL, INC.
1060 NORTH BATAVIA
UNIT H
ORANGE,  CA  92667
Correspondent Contact TIM L TRUITT
Regulation Number868.5790
Classification Product Code
BSR  
Date Received09/26/1994
Decision Date 12/21/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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