The following data is part of a premarket notification filed by Ri Mos. S.r.l. with the FDA for Cervical Anesthesia Needle, Contracervical Anesthesia Needle, Model #'s 720209 30gau X 4 Mm, 720210 30gau X 6mm, 720208g.
Device ID | K983897 |
510k Number | K983897 |
Device Name: | CERVICAL ANESTHESIA NEEDLE, CONTRACERVICAL ANESTHESIA NEEDLE, MODEL #'S 720209 30GAU X 4 MM, 720210 30GAU X 6MM, 720208G |
Classification | Set, Anesthesia, Paracervical |
Applicant | RI MOS. S.R.L. 100 MAIN ST. SUITE 120 Concord, MA 01742 |
Contact | Adena S Riemer |
Correspondent | Adena S Riemer RI MOS. S.R.L. 100 MAIN ST. SUITE 120 Concord, MA 01742 |
Product Code | HEE |
CFR Regulation Number | 884.5100 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1998-11-03 |
Decision Date | 1999-02-01 |
Summary: | summary |