The following data is part of a premarket notification filed by Inrad with the FDA for C0-axial Introducer Needle.
| Device ID | K981721 |
| 510k Number | K981721 |
| Device Name: | C0-AXIAL INTRODUCER NEEDLE |
| Classification | Instrument, Biopsy |
| Applicant | INRAD 3956 44TH ST., S.E. Kentwood, MI 49512 |
| Contact | Anne Armstrong |
| Correspondent | Anne Armstrong INRAD 3956 44TH ST., S.E. Kentwood, MI 49512 |
| Product Code | KNW |
| CFR Regulation Number | 876.1075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-05-15 |
| Decision Date | 1998-07-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10817295021071 | K981721 | 000 |
| 10817295020876 | K981721 | 000 |
| 10817295020883 | K981721 | 000 |
| 10817295020890 | K981721 | 000 |
| 10817295020906 | K981721 | 000 |
| 10817295020913 | K981721 | 000 |
| 10817295020920 | K981721 | 000 |
| 10817295020937 | K981721 | 000 |
| 10817295021040 | K981721 | 000 |
| 10817295021057 | K981721 | 000 |
| 10817295021064 | K981721 | 000 |
| 10817295020869 | K981721 | 000 |