Device Classification Name |
neurosurgical paddie
|
510(k) Number |
K854713 |
Device Name |
COTTON NEUROLOGICAL SPONGE |
Applicant |
AMERICAN SILK SUTURES, INC. |
P.O. BOX 370 |
LEDYARD,
CT
06339
|
|
Applicant Contact |
MILLER |
Correspondent |
AMERICAN SILK SUTURES, INC. |
P.O. BOX 370 |
LEDYARD,
CT
06339
|
|
Correspondent Contact |
MILLER |
Regulation Number | 882.4700
|
Classification Product Code |
|
Date Received | 11/22/1985 |
Decision Date | 03/20/1986 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|