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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 K041047
Device Name ULTRADENT CARBON MASK - UPI #342
Applicant
Medspring Group, Incorporated
533 W. 2600 S.
Suite 105
Bountiful,  UT  84010
Applicant Contact BRUCE DAVIS
Correspondent
Medspring Group, Incorporated
533 W. 2600 S.
Suite 105
Bountiful,  UT  84010
Correspondent Contact BRUCE DAVIS
Regulation Number878.4040
Classification Product Code
FXX  
Date Received04/22/2004
Decision Date 12/01/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Statement Statement
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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