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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 K802416
Device Name SALEM/RESCE INTUBATION GUIDE
Applicant
Scientific Sales Intl., Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Scientific Sales Intl., Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number868.5790
Classification Product Code
BSR  
Date Received10/06/1980
Decision Date 10/23/1980
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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