The following data is part of a premarket notification filed by Gainor Medical Europe, Ltd. with the FDA for Cleanlet, Cleanlet Xl & Kids.
| Device ID | K931827 |
| 510k Number | K931827 |
| Device Name: | CLEANLET, CLEANLET XL & KIDS |
| Classification | Lancet, Blood |
| Applicant | GAINOR MEDICAL EUROPE, LTD. P.O. BOX 353 Mcdonough, GA 30253 -0353 |
| Contact | Mark J Gainor |
| Correspondent | Mark J Gainor GAINOR MEDICAL EUROPE, LTD. P.O. BOX 353 Mcdonough, GA 30253 -0353 |
| Product Code | FMK |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-04-08 |
| Decision Date | 1993-09-13 |