Device Classification Name |
Suture, Nonabsorbable, Synthetic, Polypropylene
|
510(k) Number |
K904906 |
Device Name |
SHARPOINT POLYPROPYLENE NONABSORB SURG SUTURES USP |
Applicant |
CHATHAMBOROUGH RESEARCH GROUP, INC. |
105 WEST ST. |
P.O. BOX DRAWER 929 |
PITTSBORO,
NC
27312
|
|
Applicant Contact |
TIM HUBBARD |
Correspondent |
CHATHAMBOROUGH RESEARCH GROUP, INC. |
105 WEST ST. |
P.O. BOX DRAWER 929 |
PITTSBORO,
NC
27312
|
|
Correspondent Contact |
TIM HUBBARD |
Regulation Number | 878.5010
|
Classification Product Code |
|
Date Received | 10/25/1990 |
Decision Date | 12/24/1990 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|