Device Classification Name |
Laparoscope, General & Plastic Surgery
|
510(k) Number |
K933067 |
Device Name |
PROBES,SCISSORS,FORCEPS,GRASPERS,&NEEDLE HOLDERS |
Applicant |
MEDLINE INDUSTRIES, INC. |
ONE MEDLINE PLACE |
MUNDELEIN,
IL
60060
|
|
Applicant Contact |
DONALD BARHAM |
Correspondent |
MEDLINE INDUSTRIES, INC. |
ONE MEDLINE PLACE |
MUNDELEIN,
IL
60060
|
|
Correspondent Contact |
DONALD BARHAM |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 06/22/1993 |
Decision Date | 01/27/1994 |
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
|
|
|