The following data is part of a premarket notification filed by Richard-allan Medical Ind., Inc. with the FDA for Reflex Esi.
| Device ID | K926297 |
| 510k Number | K926297 |
| Device Name: | REFLEX ESI |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | RICHARD-ALLAN MEDICAL IND., INC. 8850 M89 BOX 351 Richland, MI 49083 |
| Contact | Julie Powell |
| Correspondent | Julie Powell RICHARD-ALLAN MEDICAL IND., INC. 8850 M89 BOX 351 Richland, MI 49083 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-12-14 |
| Decision Date | 1993-10-15 |