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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 K952689
Device Name BRIGAM MEDICAL DISPOSABLE ANESTHESIA/RESPIRATORY FACE MASK
Applicant
Owens-Brigam Medical Co.
65 Hanes Rd.
Newland,  NC  28657
Applicant Contact BILL BROOKS
Correspondent
Owens-Brigam Medical Co.
65 Hanes Rd.
Newland,  NC  28657
Correspondent Contact BILL BROOKS
Regulation Number868.5550
Classification Product Code
BSJ  
Date Received06/12/1995
Decision Date 07/11/1995
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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