The following data is part of a premarket notification filed by Richard-allan Medical Ind., Inc. with the FDA for Reflex Htr.
| Device ID | K931879 |
| 510k Number | K931879 |
| Device Name: | REFLEX HTR |
| Classification | Laparoscope, General & Plastic Surgery |
| 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 | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-04-14 |
| Decision Date | 1994-03-24 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10653405034926 | K931879 | 000 |