Device Classification Name |
plate, cranioplasty, preformed, non-alterable
|
510(k) Number |
K031034 |
Device Name |
SPIN DOWN RAPIDFLAP |
Applicant |
WALTER LORENZ SURGICAL, INC. |
1520 TRADEPORT DR. |
JACKSONVILLE,
FL
32218
|
|
Applicant Contact |
KIM REED |
Correspondent |
WALTER LORENZ SURGICAL, INC. |
1520 TRADEPORT DR. |
JACKSONVILLE,
FL
32218
|
|
Correspondent Contact |
KIM REED |
Regulation Number | 882.5330
|
Classification Product Code |
|
Date Received | 04/01/2003 |
Decision Date | 05/21/2003 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|