The following data is part of a premarket notification filed by Y with the FDA for Ivac(r) Unvented Vol. Infusion Set Model 52080.
| Device ID | K882302 |
| 510k Number | K882302 |
| Device Name: | IVAC(R) UNVENTED VOL. INFUSION SET MODEL 52080 |
| Classification | Set, Administration, Intravascular |
| Applicant | Y P.O. BOX 85335 San Diego, CA 92138 -5335 |
| Contact | Kimberly M Carlson |
| Correspondent | Kimberly M Carlson Y P.O. BOX 85335 San Diego, CA 92138 -5335 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-06-02 |
| Decision Date | 1988-07-12 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 50885403274198 | K882302 | 000 |
| 37613203011014 | K882302 | 000 |
| 37613203020849 | K882302 | 000 |
| 37613203020863 | K882302 | 000 |
| 37613203020887 | K882302 | 000 |
| 50885403220584 | K882302 | 000 |
| 50885403233584 | K882302 | 000 |
| 50885403233843 | K882302 | 000 |
| 50885403234031 | K882302 | 000 |
| 50885403234215 | K882302 | 000 |
| 50885403234543 | K882302 | 000 |
| 50885403273856 | K882302 | 000 |
| 40888277110930 | K882302 | 000 |