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 |