The following data is part of a premarket notification filed by Medtronic Ps Medical with the FDA for Medtronic Ps Medical Strata Valve, Models 42855, 42865, 92865, 92855.
Device ID | K012052 |
510k Number | K012052 |
Device Name: | MEDTRONIC PS MEDICAL STRATA VALVE, MODELS 42855, 42865, 92865, 92855 |
Classification | Shunt, Central Nervous System And Components |
Applicant | MEDTRONIC PS MEDICAL 125 CREMONA DR. Goleta, CA 93117 -5500 |
Contact | Jeff Henderson |
Correspondent | Jeff Henderson MEDTRONIC PS MEDICAL 125 CREMONA DR. Goleta, CA 93117 -5500 |
Product Code | JXG |
CFR Regulation Number | 882.5550 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2001-07-02 |
Decision Date | 2002-02-11 |
Summary: | summary |