The following data is part of a premarket notification filed by Elekta Implants, Sa with the FDA for Precision Flow Osv Ii.
| Device ID | K971799 |
| 510k Number | K971799 |
| Device Name: | PRECISION FLOW OSV II |
| Classification | Shunt, Central Nervous System And Components |
| Applicant | ELEKTA IMPLANTS, SA 6011 CELLINI ST. Coral Gables, FL 33146 |
| Contact | Barbara Ramseyer |
| Correspondent | Barbara Ramseyer ELEKTA IMPLANTS, SA 6011 CELLINI ST. Coral Gables, FL 33146 |
| Product Code | JXG |
| CFR Regulation Number | 882.5550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-05-15 |
| Decision Date | 1998-02-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00382830055635 | K971799 | 000 |