Device Classification Name |
suture, surgical, absorbable, polydioxanone
|
510(k) Number |
K030786 |
Device Name |
MONO-SWIFT |
Applicant |
CP MEDICAL |
836 N.E. 24TH AVE. |
PORTLAND,
OR
97232
|
|
Applicant Contact |
MARY ANN GREENAWALT |
Correspondent |
CP MEDICAL |
836 N.E. 24TH AVE. |
PORTLAND,
OR
97232
|
|
Correspondent Contact |
MARY ANN GREENAWALT |
Regulation Number | 878.4840
|
Classification Product Code |
|
Date Received | 03/12/2003 |
Decision Date | 05/06/2003 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Abbreviated
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|