The following data is part of a premarket notification filed by Scientific Sales Intl., Inc. with the FDA for Mywasher 5.
| Device ID | K853285 |
| 510k Number | K853285 |
| Device Name: | MYWASHER 5 |
| Classification | Device, General Purpose, Microbiology, Diagnostic |
| Applicant | SCIENTIFIC SALES INTL., INC. P.O. BOX 1538 Kalamazoo, MI 49005 |
| Contact | Nicolas Schmelzer |
| Correspondent | Nicolas Schmelzer SCIENTIFIC SALES INTL., INC. P.O. BOX 1538 Kalamazoo, MI 49005 |
| Product Code | LIB |
| CFR Regulation Number | 866.2660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-08-05 |
| Decision Date | 1985-10-04 |