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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Mask, Surgical
510(k) Number K891056
Device Name SURGICAL CONE MASK
Applicant
Dispomed, Inc.
1201 S. Flower St.
Burbank,  CA  91520
Applicant Contact KENT BRANIFF
Correspondent
Dispomed, Inc.
1201 S. Flower St.
Burbank,  CA  91520
Correspondent Contact KENT BRANIFF
Regulation Number878.4040
Classification Product Code
FXX  
Date Received02/27/1989
Decision Date 04/12/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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