The following data is part of a premarket notification filed by W. J. Medical Instruments, Inc. with the FDA for Hi-tops Electrodes 14-8000.
| Device ID | K935947 |
| 510k Number | K935947 |
| Device Name: | HI-TOPS ELECTRODES 14-8000 |
| Classification | Coagulator-cutter, Endoscopic, Unipolar (and Accessories) |
| Applicant | W. J. MEDICAL INSTRUMENTS, INC. 3537 OLD CONEJO RD. SUITE 109 Newbury Park, CA 91320 |
| Contact | William J Zinnanti |
| Correspondent | William J Zinnanti W. J. MEDICAL INSTRUMENTS, INC. 3537 OLD CONEJO RD. SUITE 109 Newbury Park, CA 91320 |
| Product Code | KNF |
| CFR Regulation Number | 884.4160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-12-13 |
| Decision Date | 1994-02-28 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| G373141066P0 | K935947 | 000 |
| G3731420100 | K935947 | 000 |
| G3731410100 | K935947 | 000 |
| G3731420080 | K935947 | 000 |
| G373141010S0 | K935947 | 000 |
| G3731405050 | K935947 | 000 |
| G3731410460 | K935947 | 000 |
| G3731415150 | K935947 | 000 |
| G3731410150 | K935947 | 000 |
| G373141004L0 | K935947 | 000 |
| G3731420150 | K935947 | 000 |
| G373141023DS0 | K935947 | 000 |
| G3731410160 | K935947 | 000 |
| G3731420200 | K935947 | 000 |
| G3731400050 | K935947 | 000 |
| G373DM15120 | K935947 | 000 |
| G373141002PA0 | K935947 | 000 |
| G373141002P0 | K935947 | 000 |
| G373DM00500 | K935947 | 000 |
| G373DM10080 | K935947 | 000 |
| G3731410560 | K935947 | 000 |
| G3731410360 | K935947 | 000 |
| G373141006P0 | K935947 | 000 |
| G373141045T0 | K935947 | 000 |
| G373141023DB0 | K935947 | 000 |
| G373141004P0 | K935947 | 000 |
| G373DS10100 | K935947 | 000 |
| G373DS10040 | K935947 | 000 |
| G373DM20200 | K935947 | 000 |
| G373DM20150 | K935947 | 000 |
| G373DM20120 | K935947 | 000 |
| G373DM20100 | K935947 | 000 |
| G373DM20080 | K935947 | 000 |
| G373DM15150 | K935947 | 000 |
| G373DM15100 | K935947 | 000 |
| G373DM15080 | K935947 | 000 |
| G373DM10100 | K935947 | 000 |
| G3731415120 | K935947 | 000 |