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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 N. Batavia
Unit H
Orange,  CA  92667
Applicant Contact TIM L TRUITT
Correspondent
Coast Medical, Inc.
1060 N. 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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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