The following data is part of a premarket notification filed by Philips Medical Systems Nederland B.v. with the FDA for Stentboost Rel. 4.
Device ID | K132305 |
510k Number | K132305 |
Device Name: | STENTBOOST REL. 4 |
Classification | Interventional Fluoroscopic X-ray System |
Applicant | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. VEENPLUIS 4-6 Best, NL 5684 Pc |
Contact | Liselotte Kornmann |
Correspondent | Liselotte Kornmann PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. VEENPLUIS 4-6 Best, NL 5684 Pc |
Product Code | OWB |
CFR Regulation Number | 892.1650 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Abbreviated |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2013-07-24 |
Decision Date | 2013-10-30 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00884838059269 | K132305 | 000 |