Conmed Vcare (Vaginal-Cervical Ahluqalia's Retractor-Elevator) Retractor/Elevator
FDA 510(k) K946220 · Conmedcorp
510(k) numberK946220
Submission
- Device name
- Conmed Vcare (Vaginal-Cervical Ahluqalia's Retractor-Elevator) Retractor/Elevator
- Applicant
- Conmedcorp
Dayton, OH, US - Received
- December 21, 1994
- Decision date
- September 15, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- LKF – Cannula, Manipulator/Injector, Uterine
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.4530
- Specialty
- Obstetrics/Gynecology
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Questions and answers
When was Conmed Vcare (Vaginal-Cervical Ahluqalia's Retractor-Elevator) Retractor/Elevator cleared by the FDA?
Conmed Vcare (Vaginal-Cervical Ahluqalia's Retractor-Elevator) Retractor/Elevator (K946220) received a 510(k) decision of Substantially Equivalent on September 15, 1995, 268 days after the submission was received.
What is the product code of K946220?
The FDA product code is LKF – Cannula, Manipulator/Injector, Uterine, a Class II (moderate risk) device regulated under 21 CFR 884.4530.