The following data is part of a premarket notification filed by Baxter Healthcare Corp. with the FDA for Homechoice/homechoice Pro Automated Personal Cycler Peritoneal Dialysis System Model 5c4471, 5c8310, 5c4471r And 5c8310r.
Device ID | K102936 |
510k Number | K102936 |
Device Name: | HOMECHOICE/HOMECHOICE PRO AUTOMATED PERSONAL CYCLER PERITONEAL DIALYSIS SYSTEM MODEL 5C4471, 5C8310, 5C4471R AND 5C8310R |
Classification | System, Peritoneal, Automatic Delivery |
Applicant | BAXTER HEALTHCARE CORP. 1620 WAUKEGAN RD. Mcgaw Park, IL 60085 |
Contact | David E Curtin |
Correspondent | David E Curtin BAXTER HEALTHCARE CORP. 1620 WAUKEGAN RD. Mcgaw Park, IL 60085 |
Product Code | FKX |
CFR Regulation Number | 876.5630 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2010-10-04 |
Decision Date | 2011-03-30 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
50085412090073 | K102936 | 000 |
50085412088438 | K102936 | 000 |
50085412087677 | K102936 | 000 |
00085412079165 | K102936 | 000 |
00085412026350 | K102936 | 000 |
00085412007038 | K102936 | 000 |
00085412007021 | K102936 | 000 |