The following data is part of a premarket notification filed by Remington Medical, Inc. with the FDA for Prostate Biopsy Needle.
| Device ID | K982401 |
| 510k Number | K982401 |
| Device Name: | PROSTATE BIOPSY NEEDLE |
| Classification | Instrument, Biopsy |
| Applicant | REMINGTON MEDICAL, INC. 6830 MEADOWRIDGE CT. Alpharetta, GA 30005 |
| Contact | Steve Woody |
| Correspondent | Steve Woody REMINGTON MEDICAL, INC. 6830 MEADOWRIDGE CT. Alpharetta, GA 30005 |
| Product Code | KNW |
| CFR Regulation Number | 876.1075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-07-10 |
| Decision Date | 1998-09-08 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20813079020985 | K982401 | 000 |
| 20813079020817 | K982401 | 000 |
| 10813079020827 | K982401 | 000 |
| 10813079020834 | K982401 | 000 |
| 10813079020841 | K982401 | 000 |
| 10813079020858 | K982401 | 000 |
| 10813079020865 | K982401 | 000 |
| 10813079020872 | K982401 | 000 |
| 20813079020886 | K982401 | 000 |
| 10813079020896 | K982401 | 000 |
| 10813079020902 | K982401 | 000 |
| 10813079020919 | K982401 | 000 |
| 20813079020923 | K982401 | 000 |
| 20813079020930 | K982401 | 000 |
| 20813079020947 | K982401 | 000 |
| 10813079020957 | K982401 | 000 |
| 10813079020964 | K982401 | 000 |
| 20813079020978 | K982401 | 000 |
| 20813079020800 | K982401 | 000 |