Device Classification Name |
holder, needle, gastroenterologic
|
510(k) Number |
K974327 |
Device Name |
WINGED NEEDLE HOLDER |
Applicant |
PHX TECHNOLOGIES CORP. |
1032 SHADY OAKS DR., NO. 100 |
DENTON,
TX
76205
|
|
Applicant Contact |
JAMES F CHAPEL, PH.D. |
Correspondent |
PHX TECHNOLOGIES CORP. |
1032 SHADY OAKS DR., NO. 100 |
DENTON,
TX
76205
|
|
Correspondent Contact |
JAMES F CHAPEL, PH.D. |
Regulation Number | 876.4730
|
Classification Product Code |
|
Date Received | 11/18/1997 |
Decision Date | 01/09/1998 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|