Device Classification Name |
Laparoscope, General & Plastic Surgery
|
510(k) Number |
K974592 |
Device Name |
INTERCEPTRE LAPAROSCOPIC INSTRUMENTS |
Applicant |
SMITH & NEPHEW, INC. |
130 FORBES BLVD. |
MANSFIELD,
MA
02048
|
|
Applicant Contact |
SUSAN A FINNERAN |
Correspondent |
SMITH & NEPHEW, INC. |
130 FORBES BLVD. |
MANSFIELD,
MA
02048
|
|
Correspondent Contact |
SUSAN A FINNERAN |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 12/09/1997 |
Decision Date | 01/12/1998 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|