The following data is part of a premarket notification filed by Baxter Healthcare Corp. with the FDA for Tur,arthroscopic,cystoscopy Irrigation Sets.
| Device ID | K960787 |
| 510k Number | K960787 |
| Device Name: | TUR,ARTHROSCOPIC,CYSTOSCOPY IRRIGATION SETS |
| Classification | System, Irrigation, Urological |
| Applicant | BAXTER HEALTHCARE CORP. RT. 120 & WILSON RD. Round Lake, IL 60073 |
| Contact | Mary-ellen Sayder |
| Correspondent | Mary-ellen Sayder BAXTER HEALTHCARE CORP. RT. 120 & WILSON RD. Round Lake, IL 60073 |
| Product Code | LJH |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-02-26 |
| Decision Date | 1996-05-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 50085412001062 | K960787 | 000 |
| 50085412001055 | K960787 | 000 |
| 50085412001031 | K960787 | 000 |
| 50085412001024 | K960787 | 000 |
| 50085412001000 | K960787 | 000 |
| 50085412000980 | K960787 | 000 |
| 50085412000973 | K960787 | 000 |
| 10653160177166 | K960787 | 000 |