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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name mouthpiece, breathing
510(k) Number K865093
Device Name SAFE-T-SHIELD MOUTHPIECE
Applicant
MEDI NUCLEAR CORP., INC.
4501 LITTLEJOHN ST.
BALDWIN PARK,  CA  91706
Applicant Contact RUSSELL W KING
Correspondent
MEDI NUCLEAR CORP., INC.
4501 LITTLEJOHN ST.
BALDWIN PARK,  CA  91706
Correspondent Contact RUSSELL W KING
Regulation Number868.5620
Classification Product Code
BYP  
Date Received12/30/1986
Decision Date 01/15/1987
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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