Device Classification Name |
suture, nonabsorbable, synthetic, polyethylene
|
510(k) Number |
K022410 |
Device Name |
SAPH-LOOP LIGATING LOOP |
Applicant |
GENZYME BIOSURGERY |
600 AIRPORT RD. |
FALL RIVER,
MA
02720 -4740
|
|
Applicant Contact |
KAREN K SYLVIA |
Correspondent |
GENZYME BIOSURGERY |
600 AIRPORT RD. |
FALL RIVER,
MA
02720 -4740
|
|
Correspondent Contact |
KAREN K SYLVIA |
Regulation Number | 878.5000
|
Classification Product Code |
|
Date Received | 07/24/2002 |
Decision Date | 08/20/2002 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|