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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name humidifier, non-direct patient interface (home-use)
510(k) Number K894734
Device Name RHINOTHERM ULTRA 2
Applicant
TWINMED PRODUCTS, INC.
2601 OCEAN PARK BLVD.
SANTA MONICA,  CA  90405
Applicant Contact EDWARD J FRANK
Correspondent
TWINMED PRODUCTS, INC.
2601 OCEAN PARK BLVD.
SANTA MONICA,  CA  90405
Correspondent Contact EDWARD J FRANK
Regulation Number868.5460
Classification Product Code
KFZ  
Date Received07/24/1989
Decision Date 02/16/1990
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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