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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 K940799
Device Name FLEXGUIDE
Applicant
SCIENTIFIC SALES INTL., INC.
P.O. BOX 1538
KALAMAZOO,  MI  49005
Applicant Contact NICHOLAS SCHMELZER
Correspondent
SCIENTIFIC SALES INTL., INC.
P.O. BOX 1538
KALAMAZOO,  MI  49005
Correspondent Contact NICHOLAS SCHMELZER
Regulation Number868.5790
Classification Product Code
BSR  
Date Received02/22/1994
Decision Date 08/18/1994
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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