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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Mask, Oxygen
510(k) Number K905288
Device Name ANESTHESIA/RESPIRATORY FACE MASK, VARIOUS SIZES
Applicant
Med-Tek Innovations, Inc.
6685 N. Sidney Pl.
Glendale,  WI  53209
Applicant Contact ALAN E WHITMARSH
Correspondent
Med-Tek Innovations, Inc.
6685 N. Sidney Pl.
Glendale,  WI  53209
Correspondent Contact ALAN E WHITMARSH
Regulation Number868.5580
Classification Product Code
BYG  
Date Received11/26/1990
Decision Date 04/09/1991
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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