The following data is part of a premarket notification filed by Aries Medical, Inc. with the FDA for Aires Tuohy Needles 17ga. X 4 1/2.
| Device ID | K850111 |
| 510k Number | K850111 |
| Device Name: | AIRES TUOHY NEEDLES 17GA. X 4 1/2 |
| Classification | Needle, Conduction, Anesthetic (w/wo Introducer) |
| Applicant | ARIES MEDICAL, INC. TWO GILL ST. Woburn, MA 01801 |
| Contact | Michael Rishton |
| Correspondent | Michael Rishton ARIES MEDICAL, INC. TWO GILL ST. Woburn, MA 01801 |
| Product Code | BSP |
| CFR Regulation Number | 868.5150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-01-14 |
| Decision Date | 1985-01-24 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 24026704664324 | K850111 | 000 |
| 24026704664317 | K850111 | 000 |
| 24026704541809 | K850111 | 000 |