The following data is part of a premarket notification filed by Phoenix Biomedical Corp. with the FDA for Perf (ommaya Style) Reservoirs.
| Device ID | K021644 |
| 510k Number | K021644 |
| Device Name: | PERF (OMMAYA STYLE) RESERVOIRS |
| Classification | Shunt, Central Nervous System And Components |
| Applicant | PHOENIX BIOMEDICAL CORP. 2495 GENERAL ARMISTEAD AVE. P.O. BOX 80390 Valley Forge, PA 19484 |
| Contact | Courtney Smith |
| Correspondent | Courtney Smith PHOENIX BIOMEDICAL CORP. 2495 GENERAL ARMISTEAD AVE. P.O. BOX 80390 Valley Forge, PA 19484 |
| Product Code | JXG |
| CFR Regulation Number | 882.5550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-05-20 |
| Decision Date | 2002-08-06 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03760124136616 | K021644 | 000 |
| 03760124133714 | K021644 | 000 |
| 03760124133721 | K021644 | 000 |
| 03760124133738 | K021644 | 000 |
| 03760124133745 | K021644 | 000 |
| 03760124134506 | K021644 | 000 |
| 03760124134513 | K021644 | 000 |
| 03760124136555 | K021644 | 000 |
| 03760124136562 | K021644 | 000 |
| 03760124136951 | K021644 | 000 |
| 03760124136968 | K021644 | 000 |
| 03760124136975 | K021644 | 000 |
| 03760124136982 | K021644 | 000 |
| 03760124136999 | K021644 | 000 |
| 03760124134537 | K021644 | 000 |
| 03760124133707 | K021644 | 000 |