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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 K952100
Device Name RUSCH ENDOTRACHEAL TUBE STYLET
Applicant
RUSCH, INC.
TALL PINES PARK
JAFFREY,  NH  03452
Applicant Contact NEIL R ARMSTRONG
Correspondent
RUSCH, INC.
TALL PINES PARK
JAFFREY,  NH  03452
Correspondent Contact NEIL R ARMSTRONG
Regulation Number868.5790
Classification Product Code
BSR  
Date Received05/04/1995
Decision Date 08/08/1995
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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