The following data is part of a premarket notification filed by Dideco S.p.a. with the FDA for D903 Avant Adult Hollow Fiber Oxygenator.
| Device ID | K980600 |
| 510k Number | K980600 |
| Device Name: | D903 AVANT ADULT HOLLOW FIBER OXYGENATOR |
| Classification | Sleeve, Limb, Compressible |
| Applicant | DIDECO S.P.A. 49 PLAIN ST. North Attleboro, MA 02760 |
| Contact | Marco Mantovani |
| Correspondent | Marco Mantovani DIDECO S.P.A. 49 PLAIN ST. North Attleboro, MA 02760 |
| Product Code | JOW |
| CFR Regulation Number | 870.5800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-02-17 |
| Decision Date | 1998-08-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 38033178250284 | K980600 | 000 |