Device Classification Name |
Retractor, Self-Retaining
|
510(k) Number |
K993544 |
Device Name |
SPACE-OR RETRACTOR |
Applicant |
ADVANCED SURGICAL CONCEPTS (ASC) |
49 PLAIN ST. |
NORTH ATTLEBORO,
MA
02760
|
|
Applicant Contact |
MARY MCNAMARA CULLINANE |
Correspondent |
ADVANCED SURGICAL CONCEPTS (ASC) |
49 PLAIN ST. |
NORTH ATTLEBORO,
MA
02760
|
|
Correspondent Contact |
MARY MCNAMARA CULLINANE |
Regulation Number | 876.4730
|
Classification Product Code |
|
Date Received | 10/19/1999 |
Decision Date | 12/22/1999 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|