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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 K953677
Device Name LIGHTED FLEXGUIDE (MODIFICATION)
Applicant
Scientific Sales Intl., Inc.
2001 Chevy Chase Blvd.
Kalamazoo,  MI  49008
Applicant Contact NICHOLAS SCHMELZER
Correspondent
Scientific Sales Intl., Inc.
2001 Chevy Chase Blvd.
Kalamazoo,  MI  49008
Correspondent Contact NICHOLAS SCHMELZER
Regulation Number868.5790
Classification Product Code
BSR  
Date Received08/07/1995
Decision Date 08/25/1995
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
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