The following data is part of a premarket notification filed by Riverpoint Medical with the FDA for Rp Cutting Needle.
Device ID | K092059 |
510k Number | K092059 |
Device Name: | RP CUTTING NEEDLE |
Classification | Instrument, Biopsy |
Applicant | RIVERPOINT MEDICAL 825 NE 25TH AVE. Portland, OR 97232 |
Contact | Doug Rowley |
Correspondent | Doug Rowley RIVERPOINT MEDICAL 825 NE 25TH AVE. Portland, OR 97232 |
Product Code | KNW |
CFR Regulation Number | 876.1075 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2009-07-07 |
Decision Date | 2009-09-24 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00812444024920 | K092059 | 000 |
00812444024913 | K092059 | 000 |
10812444022954 | K092059 | 000 |
00812444022926 | K092059 | 000 |
00812444022308 | K092059 | 000 |
30812444029148 | K092059 | 000 |
30812444029131 | K092059 | 000 |