The following data is part of a premarket notification filed by Conmed Corp. with the FDA for Aspen Surgical Systems Accessory Electrode.
| Device ID | K943542 |
| 510k Number | K943542 |
| Device Name: | ASPEN SURGICAL SYSTEMS ACCESSORY ELECTRODE |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | CONMED CORP. 3040 EAST RIVER RD. Dayton, OH 45439 |
| Contact | Ira D Duesler |
| Correspondent | Ira D Duesler CONMED CORP. 3040 EAST RIVER RD. Dayton, OH 45439 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-07-22 |
| Decision Date | 1994-09-01 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20653405032059 | K943542 | 000 |
| 40653405003213 | K943542 | 000 |
| 30653405032056 | K943542 | 000 |
| 30653405032032 | K943542 | 000 |
| 30653405003438 | K943542 | 000 |
| 30653405003407 | K943542 | 000 |
| 30653405003360 | K943542 | 000 |
| 00653405032055 | K943542 | 000 |
| 00653405032031 | K943542 | 000 |
| 00653405003437 | K943542 | 000 |
| 00653405003406 | K943542 | 000 |
| 00653405003369 | K943542 | 000 |
| 20653405003325 | K943542 | 000 |
| 20653405003332 | K943542 | 000 |
| 20653405003349 | K943542 | 000 |
| 20653405032035 | K943542 | 000 |
| 20653405003479 | K943542 | 000 |
| 20653405003462 | K943542 | 000 |
| 20653405003448 | K943542 | 000 |
| 20653405003431 | K943542 | 000 |
| 20653405003424 | K943542 | 000 |
| 20653405003417 | K943542 | 000 |
| 20653405003400 | K943542 | 000 |
| 20653405003394 | K943542 | 000 |
| 20653405003363 | K943542 | 000 |
| 20653405003356 | K943542 | 000 |
| 20653405003370 | K943542 | 000 |