Device Classification Name |
Set, Anesthesia, Paracervical
|
510(k) Number |
K954718 |
Device Name |
ELLMAN NEEDLE EXTENDER/MEASURED DOSE SYRINGE |
Applicant |
ELLMAN INTL., INC. |
30 NORTHPORT RD. |
SOUND BEACH,
NY
11789 -1734
|
|
Applicant Contact |
RICHARD C LANZILLOTTO |
Correspondent |
ELLMAN INTL., INC. |
30 NORTHPORT RD. |
SOUND BEACH,
NY
11789 -1734
|
|
Correspondent Contact |
RICHARD C LANZILLOTTO |
Regulation Number | 884.5100
|
Classification Product Code |
|
Date Received | 10/13/1995 |
Decision Date | 02/29/1996 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|