The following data is part of a premarket notification filed by Evans Medical, Inc. with the FDA for Evans Sub-q, Model Mc4206.
| Device ID | K020530 |
| 510k Number | K020530 |
| Device Name: | EVANS SUB-Q, MODEL MC4206 |
| Classification | Set, Administration, Intravascular |
| Applicant | EVANS MEDICAL, INC. P.O. BOX 7007 Deerfield, IL 60015 |
| Contact | Daniel Kamm |
| Correspondent | Daniel Kamm EVANS MEDICAL, INC. P.O. BOX 7007 Deerfield, IL 60015 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-02-19 |
| Decision Date | 2002-04-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00817708021325 | K020530 | 000 |
| 00817708021264 | K020530 | 000 |
| 00817708020588 | K020530 | 000 |