The following data is part of a premarket notification filed by Sorin Group Italia S.r.l. with the FDA for Preassembled Surgical Wash Set.
| Device ID | K103202 |
| 510k Number | K103202 |
| Device Name: | PREASSEMBLED SURGICAL WASH SET |
| Classification | Apparatus, Autotransfusion |
| Applicant | SORIN GROUP ITALIA S.R.L. 195 WEST STREET Waltham, MA 02451 |
| Contact | Barry Sall |
| Correspondent | Barry Sall SORIN GROUP ITALIA S.R.L. 195 WEST STREET Waltham, MA 02451 |
| Product Code | CAC |
| CFR Regulation Number | 868.5830 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-11-01 |
| Decision Date | 2010-11-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 38033178105249 | K103202 | 000 |
| 38033178105027 | K103202 | 000 |
| 38033178105034 | K103202 | 000 |
| 38033178105041 | K103202 | 000 |
| 38033178105058 | K103202 | 000 |
| 38033178105072 | K103202 | 000 |
| 38033178105089 | K103202 | 000 |
| 38033178105218 | K103202 | 000 |
| 38033178105225 | K103202 | 000 |
| 38033178105232 | K103202 | 000 |
| 38033178105010 | K103202 | 000 |