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 |