Device Classification Name |
Laparoscope, General & Plastic Surgery
|
510(k) Number |
K932617 |
Device Name |
S*E*M*M-SET & C*U*R*T-SET |
Applicant |
MARKET-TIERS, INC. |
8305 MELROSE DR. |
LENEXA,
KS
66214
|
|
Applicant Contact |
JAY SULLIVAN |
Correspondent |
MARKET-TIERS, INC. |
8305 MELROSE DR. |
LENEXA,
KS
66214
|
|
Correspondent Contact |
JAY SULLIVAN |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 06/01/1993 |
Decision Date | 03/07/1994 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
General & Plastic Surgery
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|