The following data is part of a premarket notification filed by Richard-allan Medical Ind., Inc. with the FDA for Reflex(r) Esc.
| Device ID | K924200 |
| 510k Number | K924200 |
| Device Name: | REFLEX(R) ESC |
| Classification | Coagulator-cutter, Endoscopic, Unipolar (and 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 | KNF |
| CFR Regulation Number | 884.4160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-08-20 |
| Decision Date | 1994-02-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20653405003455 | K924200 | 000 |
| 20653405035098 | K924200 | 000 |
| 20653405035067 | K924200 | 000 |