The following data is part of a premarket notification filed by Medtronic Ps Medical with the FDA for Medtronic Ps Medical Niveau Drainage System, Medtronic Ps Medical Niveau Drainage System Pole Clamp, Medtronic Ps Medicl.
| Device ID | K983799 |
| 510k Number | K983799 |
| Device Name: | MEDTRONIC PS MEDICAL NIVEAU DRAINAGE SYSTEM, MEDTRONIC PS MEDICAL NIVEAU DRAINAGE SYSTEM POLE CLAMP, MEDTRONIC PS MEDICL |
| Classification | Device, Monitoring, Intracranial Pressure |
| Applicant | MEDTRONIC PS MEDICAL 125 CREMONA DR. Goleta, CA 93117 -5500 |
| Contact | Jeffrey Henderson |
| Correspondent | Jeffrey Henderson MEDTRONIC PS MEDICAL 125 CREMONA DR. Goleta, CA 93117 -5500 |
| Product Code | GWM |
| CFR Regulation Number | 882.1620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-10-28 |
| Decision Date | 1999-01-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00885074280349 | K983799 | 000 |
| 00643169990906 | K983799 | 000 |
| 00643169990890 | K983799 | 000 |
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| 00643169497986 | K983799 | 000 |
| 00643169497979 | K983799 | 000 |
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| 00643169213883 | K983799 | 000 |
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| 00613994857996 | K983799 | 000 |
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| 00721902608537 | K983799 | 000 |
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| 00681490871709 | K983799 | 000 |
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| 00673978925288 | K983799 | 000 |
| 00673978779560 | K983799 | 000 |
| 00673978779553 | K983799 | 000 |
| 00763000281212 | K983799 | 000 |