Device Classification Name |
Suture, Absorbable, Natural
|
510(k) Number |
K001299 |
Device Name |
PLAIN AND CHROMIC GUT ABSORBABLE SURGICAL SUTURES USP |
Applicant |
CP MEDICAL |
836 N.E. 24TH AVE. |
PORTLAND,
OR
97232
|
|
Applicant Contact |
PATRICK FERGUSON |
Correspondent |
CP MEDICAL |
836 N.E. 24TH AVE. |
PORTLAND,
OR
97232
|
|
Correspondent Contact |
PATRICK FERGUSON |
Regulation Number | 878.4830
|
Classification Product Code |
|
Date Received | 04/24/2000 |
Decision Date | 06/23/2000 |
Decision |
SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS
(SN) |
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
|