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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 K893791
Device Name BREATHING MOUTHPIECE
Applicant
DIEMOLDING CORP.
125 RASBACH ST.
CANASTOTA,  NY  13032
Applicant Contact JEAN WALLACE
Correspondent
DIEMOLDING CORP.
125 RASBACH ST.
CANASTOTA,  NY  13032
Correspondent Contact JEAN WALLACE
Regulation Number868.5620
Classification Product Code
BYP  
Date Received05/22/1989
Decision Date 06/23/1989
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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