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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Airway, Oropharyngeal, Anesthesiology
510(k) Number K933760
Device Name STB GUEDEL AIRWAY
Applicant
Save-T-Breath Distributors C.C.
P.O.Box 87523
Houghton 2041
South Africa,  ZA
Applicant Contact C. NATES
Correspondent
Save-T-Breath Distributors C.C.
P.O.Box 87523
Houghton 2041
South Africa,  ZA
Correspondent Contact C. NATES
Regulation Number868.5110
Classification Product Code
CAE  
Date Received08/03/1993
Decision Date 03/23/1994
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
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