510(k) K983897
K983897 is an FDA 510(k) premarket notification submitted by Ri Mos. S.R.L. for the device "CERVICAL ANESTHESIA NEEDLE, CONTRACERVICAL ANESTHESIA NEEDLE, MODEL #'S 720209 30GAU X 4 MM, 720210 30GAU X 6MM, 720208G". The FDA issued a decision of Substantially Equivalent on February 1, 1999. The device falls under product code HEE (Set, Anesthesia, Paracervical), a Class II device regulated under 21 CFR 884.5100. Ri Mos. S.R.L. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 1, 1999
- Date Received
- November 3, 1998
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Set, Anesthesia, Paracervical
- Device Class
- Class II
- Regulation Number
- 884.5100
- Review Panel
- OB
- Submission Type