The following data is part of a premarket notification filed by Fiagon Gmbh with the FDA for Flexpointer 1.5 Mm.
Device ID | K150473 |
510k Number | K150473 |
Device Name: | FlexPointer 1.5 Mm |
Classification | Ear, Nose, And Throat Stereotaxic Instrument |
Applicant | FIAGON GMBH NEUENDORFSTR. 23B Hennigsdorf, DE 16761 |
Contact | Dr. Dirk Mucha |
Correspondent | Dr. Dirk Mucha FIAGON GMBH NEUENDORFSTR. 23B Hennigsdorf, DE 16761 |
Product Code | PGW |
CFR Regulation Number | 882.4560 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2015-02-23 |
Decision Date | 2015-04-16 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
EFIAE0120041 | K150473 | 000 |