The following data is part of a premarket notification filed by Remington Medical, Inc. with the FDA for Needle Guide.
| Device ID | K983621 |
| 510k Number | K983621 |
| Device Name: | NEEDLE GUIDE |
| Classification | System, X-ray, Mammographic |
| 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 | IZH |
| CFR Regulation Number | 892.1710 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-10-15 |
| Decision Date | 1998-11-03 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10813079020421 | K983621 | 000 |
| 20813079020411 | K983621 | 000 |
| 10813079020407 | K983621 | 000 |