510(k) K983897

CERVICAL ANESTHESIA NEEDLE, CONTRACERVICAL ANESTHESIA NEEDLE, MODEL #'S 720209 30GAU X 4 MM, 720210 30GAU X 6MM, 720208G by Ri Mos. S.R.L. — Product Code HEE

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