The following data is part of a premarket notification filed by Richard-allan Medical with the FDA for Reflex(r) Eca.
| Device ID | K924929 |
| 510k Number | K924929 |
| Device Name: | REFLEX(R) ECA |
| Classification | Applier, Hemostatic Clip |
| Applicant | RICHARD-ALLAN MEDICAL 8850M89, BOX 351 Richland, MI 49083 |
| Contact | Julie Powell |
| Correspondent | Julie Powell RICHARD-ALLAN MEDICAL 8850M89, BOX 351 Richland, MI 49083 |
| Product Code | HBT |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-09-30 |
| Decision Date | 1993-07-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20653405074813 | K924929 | 000 |