Device Classification Name |
laparoscope, general & plastic surgery
|
510(k) Number |
K936102 |
Device Name |
DAVOL LAPAROSCOPIC INSUFFLATION NEEDLE FOR GENERAL LAPAROSCOPIC PROCEDURES |
Applicant |
DAVOL, INC., SUB. C.R. BARD, INC. |
100 SOCKANOSSETT CROSSROAD |
P.O. BOX 8500 |
CRANSTON,
RI
02920
|
|
Applicant Contact |
JEANETTE G CLOUTIER |
Correspondent |
DAVOL, INC., SUB. C.R. BARD, INC. |
100 SOCKANOSSETT CROSSROAD |
P.O. BOX 8500 |
CRANSTON,
RI
02920
|
|
Correspondent Contact |
JEANETTE G CLOUTIER |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 12/22/1993 |
Decision Date | 05/17/1994 |
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
|
|
|