The following data is part of a premarket notification filed by Aspen Surgical Products, Inc. with the FDA for Cautery Tip Cleaner, Model-tc-100.
| Device ID | K030339 |
| 510k Number | K030339 |
| Device Name: | CAUTERY TIP CLEANER, MODEL-TC-100 |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | ASPEN SURGICAL PRODUCTS, INC. 7425 CLYDE PARK, SUITE G Byron Center, MI 49315 |
| Contact | Debbie Daly |
| Correspondent | Debbie Daly ASPEN SURGICAL PRODUCTS, INC. 7425 CLYDE PARK, SUITE G Byron Center, MI 49315 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-01-31 |
| Decision Date | 2003-03-07 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 50885380011847 | K030339 | 000 |
| 10612479138213 | K030339 | 000 |
| 00840113228119 | K030339 | 000 |
| 00840113228089 | K030339 | 000 |
| 00840113227112 | K030339 | 000 |
| 00840113227082 | K030339 | 000 |
| 00840113227068 | K030339 | 000 |
| 00840113228072 | K030339 | 000 |
| 00840113205677 | K030339 | 000 |
| 20809160003210 | K030339 | 000 |
| 50885632127081 | K030339 | 000 |
| 20809160023690 | K030339 | 000 |
| 10887761000367 | K030339 | 000 |
| 20887761000357 | K030339 | 000 |
| 10887761000343 | K030339 | 000 |
| 10887761000336 | K030339 | 000 |
| 00887761000322 | K030339 | 000 |
| 00887761000315 | K030339 | 000 |
| 10887761000305 | K030339 | 000 |
| 10884389063453 | K030339 | 000 |