The following data is part of a premarket notification filed by Medcomp with the FDA for Raulerson One-step Guidewire Insertion Bulb Needle.
| Device ID | K971281 |
| 510k Number | K971281 |
| Device Name: | RAULERSON ONE-STEP GUIDEWIRE INSERTION BULB NEEDLE |
| Classification | Wire, Guide, Catheter |
| Applicant | MEDCOMP 1499 DELP DR. Harleysville, PA 19438 |
| Contact | Jeanne M Cush |
| Correspondent | Jeanne M Cush MEDCOMP 1499 DELP DR. Harleysville, PA 19438 |
| Product Code | DQX |
| CFR Regulation Number | 870.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-04-07 |
| Decision Date | 1997-10-09 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20809160321727 | K971281 | 000 |
| 20809160067458 | K971281 | 000 |