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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name spirometer, therapeutic (incentive)
510(k) Number K962749
Device Name THERAPEP W/MOUTHPIECE, W/PEDIATRIC MASK, W/SMALL MASK, W/LARGE MASK, RESISTOR/PORT/MOUTHPIECE, RESISTOR/PORT
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 Number868.5690
Classification Product Code
BWF  
Date Received07/15/1996
Decision Date 10/10/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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