The following data is part of a premarket notification filed by Conkin Surgical Instruments Ltd. with the FDA for Single Channel Balloon Cannula.
| Device ID | K974801 |
| 510k Number | K974801 |
| Device Name: | SINGLE CHANNEL BALLOON CANNULA |
| Classification | Elevator, Uterine |
| Applicant | CONKIN SURGICAL INSTRUMENTS LTD. P.O.BOX 6707, STATION "A" Toronta, Ontario, CA M5w 1x5 |
| Contact | Kina Markoff |
| Correspondent | Kina Markoff CONKIN SURGICAL INSTRUMENTS LTD. P.O.BOX 6707, STATION "A" Toronta, Ontario, CA M5w 1x5 |
| Product Code | HDP |
| CFR Regulation Number | 884.4530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-12-22 |
| Decision Date | 1998-07-09 |