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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Mask, Gas, Anesthetic
510(k) Number K950771
Device Name DISPOSABLE ADHESIVE FACE MASK
Applicant
Advanced Warming Systems, Inc.
3414 22nd. St.
Lubbock,  TX  79410
Applicant Contact RANDY HICKLE
Correspondent
Advanced Warming Systems, Inc.
3414 22nd. St.
Lubbock,  TX  79410
Correspondent Contact RANDY HICKLE
Regulation Number868.5550
Classification Product Code
BSJ  
Date Received02/21/1994
Decision Date 03/10/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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