The following data is part of a premarket notification filed by Alcide Corp. with the FDA for Alcide Ren New-d.
Device ID | K844734 |
510k Number | K844734 |
Device Name: | ALCIDE REN NEW-D |
Classification | System, Dialysate Delivery, Central Multiple Patient |
Applicant | ALCIDE CORP. 125 MAIN ST. Westport, CT 06880 |
Contact | Harry M Kaufman |
Correspondent | Harry M Kaufman ALCIDE CORP. 125 MAIN ST. Westport, CT 06880 |
Product Code | FKQ |
CFR Regulation Number | 876.5820 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-12-04 |
Decision Date | 1985-05-17 |