The following data is part of a premarket notification filed by Baxter Healthcare Corp. with the FDA for The Pudenz In Line Valve.
| Device ID | K894072 |
| 510k Number | K894072 |
| Device Name: | THE PUDENZ IN LINE VALVE |
| Classification | Shunt, Central Nervous System And Components |
| Applicant | BAXTER HEALTHCARE CORP. 7280 NORTH CALDWELL Niles, IL 60648 |
| Contact | Jeanne Morizio |
| Correspondent | Jeanne Morizio BAXTER HEALTHCARE CORP. 7280 NORTH CALDWELL Niles, IL 60648 |
| Product Code | JXG |
| CFR Regulation Number | 882.5550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-06-08 |
| Decision Date | 1989-08-07 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10381780072201 | K894072 | 000 |