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 |