The following data is part of a premarket notification filed by Euro-med Intl. with the FDA for Prostatic Core-cut Needle.
| Device ID | K883884 |
| 510k Number | K883884 |
| Device Name: | PROSTATIC CORE-CUT NEEDLE |
| Classification | Instrument, Biopsy |
| Applicant | EURO-MED INTL. 79 KOSMAS ST. Marlborough, MA 01752 |
| Contact | Jorgen H Madsen |
| Correspondent | Jorgen H Madsen EURO-MED INTL. 79 KOSMAS ST. Marlborough, MA 01752 |
| Product Code | KNW |
| CFR Regulation Number | 876.1075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-09-13 |
| Decision Date | 1988-12-05 |