Device Classification Name |
Suture, Absorbable, Synthetic, Polyglycolic Acid
|
510(k) Number |
K072028 |
Device Name |
QUILL SELF-RETAINING SYSTEM (SRS) COMPRISED OF MONODERM |
Applicant |
SURGICAL SPECIALTIES CORP. |
100 DENNIS DR. |
READING,
PA
19606
|
|
Applicant Contact |
LOIS SMART |
Correspondent |
SURGICAL SPECIALTIES CORP. |
100 DENNIS DR. |
READING,
PA
19606
|
|
Correspondent Contact |
LOIS SMART |
Regulation Number | 878.4493
|
Classification Product Code |
|
Date Received | 07/24/2007 |
Decision Date | 08/03/2007 |
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
|