Device Classification Name |
Set, Anesthesia, Paracervical
|
510(k) Number |
K980238 |
Device Name |
GYNEX EXTENDED REACH NEEDLE |
Applicant |
GYNEX CORP. |
1000 BURNETT AVE. |
SUITE 450 |
CONCORD,
CA
94520
|
|
Applicant Contact |
DAVID W SCHLERF |
Correspondent |
GYNEX CORP. |
1000 BURNETT AVE. |
SUITE 450 |
CONCORD,
CA
94520
|
|
Correspondent Contact |
DAVID W SCHLERF |
Regulation Number | 884.5100
|
Classification Product Code |
|
Date Received | 01/23/1998 |
Decision Date | 08/21/1998 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|