The following data is part of a premarket notification filed by Conmed Corp. with the FDA for Conmed Vcare (vaginal-cervical Ahluqalia's Retractor-elevator) Retractor/elevator.
Device ID | K946220 |
510k Number | K946220 |
Device Name: | CONMED VCARE (VAGINAL-CERVICAL AHLUQALIA'S RETRACTOR-ELEVATOR) RETRACTOR/ELEVATOR |
Classification | Cannula, Manipulator/injector, Uterine |
Applicant | CONMED CORP. P.O. BOX 1408 Dayton, OH 45401 -1408 |
Contact | Ira D Duesler, Jr. |
Correspondent | Ira D Duesler, Jr. CONMED CORP. P.O. BOX 1408 Dayton, OH 45401 -1408 |
Product Code | LKF |
CFR Regulation Number | 884.4530 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-12-21 |
Decision Date | 1995-09-15 |