The following data is part of a premarket notification filed by Waters Assoc., Inc. with the FDA for Wisp Model 710.
| Device ID | K772311 |
| 510k Number | K772311 |
| Device Name: | WISP MODEL 710 |
| Classification | Enzymatic Esterase--oxidase, Cholesterol |
| Applicant | WATERS ASSOC., INC. ND |
| Product Code | CHH |
| CFR Regulation Number | 862.1175 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1977-12-19 |
| Decision Date | 1978-01-12 |