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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 K872015
Device Name SPIRASEAL(TM) FACE MASK (VARIOUS SIZES)
Applicant
BRIGAM, INC.
103 NORTH STERLING ST.
MORGANTON,  NC  28655
Applicant Contact C. E GAMMONS
Correspondent
BRIGAM, INC.
103 NORTH STERLING ST.
MORGANTON,  NC  28655
Correspondent Contact C. E GAMMONS
Regulation Number868.5550
Classification Product Code
BSJ  
Date Received05/26/1987
Decision Date 06/17/1987
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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