The following data is part of a premarket notification filed by Prismedical Corp. with the FDA for Mainstream Water Purification Device.
| Device ID | K012716 |
| 510k Number | K012716 |
| Device Name: | MAINSTREAM WATER PURIFICATION DEVICE |
| Classification | System, Water Purification, General Medical Use |
| Applicant | PRISMEDICAL CORP. 1100 TRANCAS ST., STE. 250 Napa, CA 94558 |
| Contact | Elaine Alambra |
| Correspondent | Elaine Alambra PRISMEDICAL CORP. 1100 TRANCAS ST., STE. 250 Napa, CA 94558 |
| Product Code | NHV |
| CFR Regulation Number | 876.5665 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-08-15 |
| Decision Date | 2002-05-07 |
| Summary: | summary |