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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name methyl methacrylate for cranioplasty
510(k) Number K091382
Device Name KRYPTONITE BONE CEMENT
Applicant
DOCTORS RESEARCH GROUP, INC.
1331 H STREET NW 12TH FLOOR
WASHINGTON,  DC  20005
Applicant Contact JUSTIN EGGLETON
Correspondent
DOCTORS RESEARCH GROUP, INC.
1331 H STREET NW 12TH FLOOR
WASHINGTON,  DC  20005
Correspondent Contact JUSTIN EGGLETON
Regulation Number882.5300
Classification Product Code
GXP  
Date Received05/11/2009
Decision Date 11/16/2009
Decision SE - With Limitations (SESU)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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