The following data is part of a premarket notification filed by Baxter Healthcare Corp. with the FDA for Modified Blood Recipient Set.
| Device ID | K993120 |
| 510k Number | K993120 |
| Device Name: | MODIFIED BLOOD RECIPIENT SET |
| Classification | Set, Blood Transfusion |
| Applicant | BAXTER HEALTHCARE CORP. RT. 120 & WILSON RD. Round Lake, IL 60073 |
| Contact | Judy Kannenberg |
| Correspondent | Judy Kannenberg BAXTER HEALTHCARE CORP. RT. 120 & WILSON RD. Round Lake, IL 60073 |
| Product Code | BRZ |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-09-20 |
| Decision Date | 1999-11-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 50085412079535 | K993120 | 000 |
| 50085412004001 | K993120 | 000 |
| 50085412004131 | K993120 | 000 |
| 50085412013775 | K993120 | 000 |
| 50085412044816 | K993120 | 000 |
| 50085412046124 | K993120 | 000 |
| 50085412046346 | K993120 | 000 |
| 50085412049071 | K993120 | 000 |
| 50085412049088 | K993120 | 000 |
| 50085412068157 | K993120 | 000 |
| 50085412072987 | K993120 | 000 |
| 50085412072994 | K993120 | 000 |
| 50085412073588 | K993120 | 000 |
| 50085412074837 | K993120 | 000 |
| 50085412002403 | K993120 | 000 |