The following data is part of a premarket notification filed by Erika, Inc. with the FDA for Erika Capd Prep Kit #30-9501-5.
Device ID | K820179 |
510k Number | K820179 |
Device Name: | ERIKA CAPD PREP KIT #30-9501-5 |
Classification | System, Peritoneal, Automatic Delivery |
Applicant | ERIKA, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | FKX |
CFR Regulation Number | 876.5630 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1982-01-22 |
Decision Date | 1982-02-19 |