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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 K870206
Device Name CRYSTAL MASK
Applicant
Brunswick Mfg. Co., Inc.
90 Myrtle St.
North Quincy,  MA  02171
Applicant Contact ROY H HEWSON
Correspondent
Brunswick Mfg. Co., Inc.
90 Myrtle St.
North Quincy,  MA  02171
Correspondent Contact ROY H HEWSON
Regulation Number868.5580
Classification Product Code
BYG  
Date Received01/20/1987
Decision Date 02/20/1987
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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