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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name anesthesia conduction kit
510(k) Number K881429
Device Name YANKAUER SUCTION INSTRU./LAYTEX GLOVES/SUCT. CATH.
Applicant
MEDICAL REPACKERS CO.
P.O. BOX 1500
FORT PAYNE,  AL  35967
Applicant Contact BILLY A HODGES
Correspondent
MEDICAL REPACKERS CO.
P.O. BOX 1500
FORT PAYNE,  AL  35967
Correspondent Contact BILLY A HODGES
Regulation Number868.5140
Classification Product Code
CAZ  
Date Received03/29/1988
Decision Date 04/25/1988
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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