The following data is part of a premarket notification filed by Mar Cor Services, Inc. with the FDA for Mar Cor Services Semper Pure Ro Machine.
Device ID | K003877 |
510k Number | K003877 |
Device Name: | MAR COR SERVICES SEMPER PURE RO MACHINE |
Classification | Subsystem, Water Purification |
Applicant | MAR COR SERVICES, INC. 364 MAPLE AVE. Harleysville, PA 19438 |
Contact | Andrew G Stitzinger |
Correspondent | Andrew G Stitzinger MAR COR SERVICES, INC. 364 MAPLE AVE. Harleysville, PA 19438 |
Product Code | FIP |
CFR Regulation Number | 876.5665 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Abbreviated |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2000-12-15 |
Decision Date | 2001-06-22 |