The following data is part of a premarket notification filed by Millipore Corp. with the FDA for Hemo-ro Water Purification Sys.
Device ID | K841403 |
510k Number | K841403 |
Device Name: | HEMO-RO WATER PURIFICATION SYS |
Classification | Subsystem, Water Purification |
Applicant | MILLIPORE CORP. 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | FIP |
CFR Regulation Number | 876.5665 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-04-03 |
Decision Date | 1984-07-06 |