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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cannula, Nasal, Oxygen
510(k) Number K921496
Device Name SKIN SAVER(TM) TUBING HOLDER, MODEL 1921 MODIFIED
Applicant
ALPINE SPECIALTIES, INC.
640 E. EISENHOWER
LOVELAND,  CO  80537
Applicant Contact ROBIN PASQUAROSA
Correspondent
ALPINE SPECIALTIES, INC.
640 E. EISENHOWER
LOVELAND,  CO  80537
Correspondent Contact ROBIN PASQUAROSA
Regulation Number868.5340
Classification Product Code
CAT  
Date Received03/09/1992
Decision Date 08/14/1992
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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