The following data is part of a premarket notification filed by The Kendall Company with the FDA for Filac Fas Temp Electronic Thermometer.
| Device ID | K003313 |
| 510k Number | K003313 |
| Device Name: | FILAC FAS TEMP ELECTRONIC THERMOMETER |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | THE KENDALL COMPANY 444 MCDONNELL BLVD. Hazelwood, MO 63042 |
| Contact | Kelly J Rowland |
| Correspondent | Kelly J Rowland THE KENDALL COMPANY 444 MCDONNELL BLVD. Hazelwood, MO 63042 |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-10-23 |
| Decision Date | 2001-01-11 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20884521008530 | K003313 | 000 |
| 10884521210318 | K003313 | 000 |
| 10884521210325 | K003313 | 000 |
| 10884521210332 | K003313 | 000 |
| 10192253013689 | K003313 | 000 |
| 10192253013696 | K003313 | 000 |
| 10192253013702 | K003313 | 000 |
| 20612479195954 | K003313 | 000 |
| 50884521008081 | K003313 | 000 |
| 30884521008131 | K003313 | 000 |
| 20884521008257 | K003313 | 000 |
| 30884521008292 | K003313 | 000 |
| 20884521008370 | K003313 | 000 |
| 20884521008455 | K003313 | 000 |
| 20884521008462 | K003313 | 000 |
| 20884521008509 | K003313 | 000 |
| 20884521008356 | K003313 | 000 |