The following data is part of a premarket notification filed by Wallach Surgical Devices, Inc. with the FDA for Wa-2000 Temperature Indicator.
| Device ID | K813402 |
| 510k Number | K813402 |
| Device Name: | WA-2000 TEMPERATURE INDICATOR |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | WALLACH SURGICAL DEVICES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-12-04 |
| Decision Date | 1982-01-12 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00888937014013 | K813402 | 000 |