The following data is part of a premarket notification filed by D.i.r.r.a. S.r.l. with the FDA for Surgical Drape Kit - D.i.r.r.a. Srl.
| Device ID | K041080 |
| 510k Number | K041080 |
| Device Name: | SURGICAL DRAPE KIT - D.I.R.R.A. SRL |
| Classification | General Surgery Tray |
| Applicant | D.I.R.R.A. S.R.L. 26, VIA GUIDO ROSSA (Z.I. GERBOLINA) Viadana, Mantova, IT I - 46019 |
| Contact | Elisabetta Bacchi |
| Correspondent | Elisabetta Bacchi D.I.R.R.A. S.R.L. 26, VIA GUIDO ROSSA (Z.I. GERBOLINA) Viadana, Mantova, IT I - 46019 |
| Product Code | LRO |
| CFR Regulation Number | 878.4370 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-04-26 |
| Decision Date | 2004-11-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 38032248127402 | K041080 | 000 |