Device Classification Name |
needle, fistula
|
510(k) Number |
K990803 |
Device Name |
MEDISYSTEMS BUTTONHOLE NEEDLE SETS |
Applicant |
MEDISYSTEMS CORP. |
1900 K STREET, N.W. |
WASHINGTON,
DC
20006
|
|
Applicant Contact |
LARRY R PILOT |
Correspondent |
MEDISYSTEMS CORP. |
1900 K STREET, N.W. |
WASHINGTON,
DC
20006
|
|
Correspondent Contact |
LARRY R PILOT |
Regulation Number | 876.5540
|
Classification Product Code |
|
Date Received | 03/10/1999 |
Decision Date | 01/06/2000 |
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
|
Recalls |
CDRH Recalls
|
|
|