Device Classification Name |
accessories, catheter, g-u |
|||
---|---|---|---|---|
510(k) Number | K991097 | |||
Device Name | PBN DRAINAGE CATHETER GUIDEWIRES | |||
Applicant |
|
|||
Applicant Contact | karl swartz | |||
Correspondent |
|
|||
Correspodent Contact | karl swartz | |||
Regulation Number | 876.5130 | |||
Classification Product Code |
|
|||
Date Received | 04/01/1999 | |||
Decision Date | 04/23/1999 | |||
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 |