The following data is part of a premarket notification filed by White Knight Healthcare with the FDA for Surgical Tip Cleaner.
| Device ID | K942577 |
| 510k Number | K942577 |
| Device Name: | SURGICAL TIP CLEANER |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | WHITE KNIGHT HEALTHCARE P.O. BOX 6874 175 DEAVERVIEW ROAD Asheville, NC 28816 |
| Contact | Frank Dastoli |
| Correspondent | Frank Dastoli WHITE KNIGHT HEALTHCARE P.O. BOX 6874 175 DEAVERVIEW ROAD Asheville, NC 28816 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-05-31 |
| Decision Date | 1994-07-26 |