Device Classification Name |
Suture, Absorbable, Natural
|
510(k) Number |
K961931 |
Device Name |
PLAIN GUT & CHRONIC GUT ABSORBABLE SURGICAL SUTURES USP |
Applicant |
R.K. MEDICAL, L.L.C. |
ONE LETHBRIDGE PLAZA |
SUITE 4 |
MAHWAH,
NJ
07430
|
|
Applicant Contact |
BRENDA M KELLY |
Correspondent |
R.K. MEDICAL, L.L.C. |
ONE LETHBRIDGE PLAZA |
SUITE 4 |
MAHWAH,
NJ
07430
|
|
Correspondent Contact |
BRENDA M KELLY |
Regulation Number | 878.4830
|
Classification Product Code |
|
Date Received | 05/17/1996 |
Decision Date | 07/29/1996 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|