Device Classification Name |
laparoscope, gynecologic (and accessories)
|
510(k) Number |
K944245 |
Device Name |
DYNABITE LAPAROSCOPIC FORCEPS |
Applicant |
PORTLYN CORP. |
RFD #1 BOX 451, ROUTE 25 |
MOULTONBORO,
NH
03254
|
|
Applicant Contact |
GEORGE A LYNA |
Correspondent |
PORTLYN CORP. |
RFD #1 BOX 451, ROUTE 25 |
MOULTONBORO,
NH
03254
|
|
Correspondent Contact |
GEORGE A LYNA |
Regulation Number | 884.1720
|
Classification Product Code |
|
Date Received | 08/30/1994 |
Decision Date | 11/15/1994 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|