Device Classification Name |
Laparoscope, General & Plastic Surgery
|
510(k) Number |
K032680 |
Device Name |
SMITH & NEPHEW 300XL XENON LIGHT SOURCE-HERMES READY MODEL, 7210045 |
Applicant |
SMITH & NEPHEW, INC. |
150 MINUTEMAN RD. |
ANDOVER,
MA
01810
|
|
Applicant Contact |
DEBORAH CONNORS |
Correspondent |
SMITH & NEPHEW, INC. |
150 MINUTEMAN RD. |
ANDOVER,
MA
01810
|
|
Correspondent Contact |
DEBORAH CONNORS |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 08/29/2003 |
Decision Date | 09/26/2003 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|