The following data is part of a premarket notification filed by Kleen Test Products with the FDA for Sure Count Light Handle Cover.
| Device ID | K890539 |
| 510k Number | K890539 |
| Device Name: | SURE COUNT LIGHT HANDLE COVER |
| Classification | Light, Surgical, Accessories |
| Applicant | KLEEN TEST PRODUCTS P.O. BOX 140 Elkhorn, WI 53121 |
| Contact | Gary L Swanson |
| Correspondent | Gary L Swanson KLEEN TEST PRODUCTS P.O. BOX 140 Elkhorn, WI 53121 |
| Product Code | FTA |
| CFR Regulation Number | 878.4580 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-02-03 |
| Decision Date | 1989-02-27 |