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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 K912197
Device Name SKIN SAVER(TM) TUBING HOLDER, MODEL 467
Applicant
ALPINE SPECIALTIES, INC.
640 E. EISENHOWER
LOVELAND,  CO  80537
Applicant Contact ROBIN J PASQUAROSA
Correspondent
ALPINE SPECIALTIES, INC.
640 E. EISENHOWER
LOVELAND,  CO  80537
Correspondent Contact ROBIN J PASQUAROSA
Regulation Number868.5340
Classification Product Code
CAT  
Date Received05/17/1991
Decision Date 08/20/1991
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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