510(k) Premarket Notification Database
Device Classification Name |
catheter, retention type, balloon
|
510(k) Number | K944376 |
Device Name | ORION ALL SILICONE ELASTOMER COATED CATHETER |
Applicant |
REGULATORY & MARKETING SERVICES, INC.
|
1247 florida ave. |
palm harbor,
FL
34682 |
|
Contact | patrick j lamb |
Regulation Number | 876.5130 |
Classification Product Code |
|
Date Received | 09/07/1994 |
Decision Date | 11/30/1994 |
Decision |
substantially equivalent (SE) |
Classification Advisory Committee |
Gastroenterology/Urology
|
Review Advisory Committee |
Gastroenterology/Urology
|
Statement/Summary/Purged Status |
Statement/purged 510(k)
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Expedited Review |
|
|
|