The following data is part of a premarket notification filed by Richard-allan Medical with the FDA for Reflex Ins Insufflation Needle.
| Device ID | K942207 |
| 510k Number | K942207 |
| Device Name: | REFLEX INS INSUFFLATION NEEDLE |
| Classification | Insufflator, Laparoscopic |
| Applicant | RICHARD-ALLAN MEDICAL 8850 M89, BOX 351 Richland, MI 49083 -0351 |
| Contact | Julie Powell |
| Correspondent | Julie Powell RICHARD-ALLAN MEDICAL 8850 M89, BOX 351 Richland, MI 49083 -0351 |
| Product Code | HIF |
| CFR Regulation Number | 884.1730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-05-05 |
| Decision Date | 1994-05-27 |