The following data is part of a premarket notification filed by Biomedix, Inc. with the FDA for Selec-3 I.v.administration Set.
| Device ID | K142097 |
| 510k Number | K142097 |
| Device Name: | SELEC-3 I.V.ADMINISTRATION SET |
| Classification | Set, Administration, Intravascular |
| Applicant | BIOMEDIX, INC. 3895 WEST VERNAL PIKE Blmgtn, IN 47404 |
| Contact | Myra J Bender |
| Correspondent | Myra J Bender BIOMEDIX, INC. 3895 WEST VERNAL PIKE Blmgtn, IN 47404 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-08-01 |
| Decision Date | 2014-08-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00851470007156 | K142097 | 000 |
| 00851470007019 | K142097 | 000 |
| 00851470007026 | K142097 | 000 |
| 00851470007033 | K142097 | 000 |
| 00851470007040 | K142097 | 000 |
| 00851470007057 | K142097 | 000 |
| 00851470007064 | K142097 | 000 |
| 00851470007071 | K142097 | 000 |
| 00851470007088 | K142097 | 000 |
| 00851470007095 | K142097 | 000 |
| 00851470007101 | K142097 | 000 |
| 00851470007118 | K142097 | 000 |
| 00851470007125 | K142097 | 000 |
| 00851470007132 | K142097 | 000 |
| 00851470007149 | K142097 | 000 |
| 00851470007002 | K142097 | 000 |