Device Classification Name |
Retractor, Self-Retaining, For Neurosurgery
|
510(k) Number |
K882071 |
Device Name |
CRANK FRAME RETRACTOR |
Applicant |
KARLIN TECHNOLOGY, INC. |
330 WASHINGTON ST. |
SUITE 314 |
MARINA DEL REY,
CA
90292
|
|
Applicant Contact |
MARK WEIDHAAS |
Correspondent |
KARLIN TECHNOLOGY, INC. |
330 WASHINGTON ST. |
SUITE 314 |
MARINA DEL REY,
CA
90292
|
|
Correspondent Contact |
MARK WEIDHAAS |
Regulation Number | 882.4800
|
Classification Product Code |
|
Date Received | 05/17/1988 |
Decision Date | 06/10/1988 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|