The following data is part of a premarket notification filed by Smt Swiss Microtechnology Ag with the FDA for Pascal Dynamic Contour Tonometer.
| Device ID | K032967 |
| 510k Number | K032967 |
| Device Name: | PASCAL DYNAMIC CONTOUR TONOMETER |
| Classification | Tonometer, Manual |
| Applicant | SMT SWISS MICROTECHNOLOGY AG 13 RED FOX LANE Littleton, CO 80127 |
| Contact | Kevin Walls |
| Correspondent | Kevin Walls SMT SWISS MICROTECHNOLOGY AG 13 RED FOX LANE Littleton, CO 80127 |
| Product Code | HKY |
| CFR Regulation Number | 886.1930 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-09-23 |
| Decision Date | 2003-11-14 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07640167751174 | K032967 | 000 |