The following data is part of a premarket notification filed by Molded Products Inc. with the FDA for Disposable Storage Cap.
Device ID | K010366 |
510k Number | K010366 |
Device Name: | DISPOSABLE STORAGE CAP |
Classification | Dialyzer, Capillary, Hollow Fiber |
Applicant | MOLDED PRODUCTS INC. P.O. BOX 15 Harlan, IA 51537 |
Contact | Elise Johnston |
Correspondent | Elise Johnston MOLDED PRODUCTS INC. P.O. BOX 15 Harlan, IA 51537 |
Product Code | FJI |
CFR Regulation Number | 876.5820 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Abbreviated |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2001-02-07 |
Decision Date | 2001-11-28 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
B144MPC40S1 | K010366 | 000 |