The following data is part of a premarket notification filed by Medtronic Neurosurgery with the FDA for Medtronic Ps Medical Strata Type Value.
Device ID | K060681 |
510k Number | K060681 |
Device Name: | MEDTRONIC PS MEDICAL STRATA TYPE VALUE |
Classification | Shunt, Central Nervous System And Components |
Applicant | MEDTRONIC NEUROSURGERY 125 CREMONA DR. Goleta, CA 93117 |
Contact | Jeffrey Henderson |
Correspondent | Jeffrey Henderson MEDTRONIC NEUROSURGERY 125 CREMONA DR. Goleta, CA 93117 |
Product Code | JXG |
CFR Regulation Number | 882.5550 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2006-03-15 |
Decision Date | 2006-09-15 |
Summary: | summary |