The following data is part of a premarket notification filed by Cedic S.r.l. with the FDA for F00010 - Iv Gravity Setwith Male Luer Slip; F00027 - Iv Gravity Set With Male Luer Lock.
| Device ID | K042129 |
| 510k Number | K042129 |
| Device Name: | F00010 - IV GRAVITY SETWITH MALE LUER SLIP; F00027 - IV GRAVITY SET WITH MALE LUER LOCK |
| Classification | Set, Administration, Intravascular |
| Applicant | CEDIC S.R.L. VIA LIBERAZIONE, 63/9 Peschiera Borromeo Milan(lomb), IT 20068 |
| Contact | Giancarlo Gagliardoni |
| Correspondent | Giancarlo Gagliardoni CEDIC S.R.L. VIA LIBERAZIONE, 63/9 Peschiera Borromeo Milan(lomb), IT 20068 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-08-06 |
| Decision Date | 2005-01-27 |
| Summary: | summary |