The following data is part of a premarket notification filed by Medro Systems, Inc. with the FDA for Reverse Osmosis Water Purification System.
| Device ID | K871242 |
| 510k Number | K871242 |
| Device Name: | REVERSE OSMOSIS WATER PURIFICATION SYSTEM |
| Classification | Subsystem, Water Purification |
| Applicant | MEDRO SYSTEMS, INC. 416 EAST INDUSTRIAL BLVD. Mckinney, TX 75069 |
| Contact | Joan C Stivers |
| Correspondent | Joan C Stivers MEDRO SYSTEMS, INC. 416 EAST INDUSTRIAL BLVD. Mckinney, TX 75069 |
| Product Code | FIP |
| CFR Regulation Number | 876.5665 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-03-27 |
| Decision Date | 1988-03-16 |