The following data is part of a premarket notification filed by Banta Healthcare Group, Ltd. with the FDA for Sanitherm Oral Disposable Thermometer Sheaths For Mercury Thermometer, Senitherm Oral Disposable Thermometer Sheaths For.
| Device ID | K983406 |
| 510k Number | K983406 |
| Device Name: | SANITHERM ORAL DISPOSABLE THERMOMETER SHEATHS FOR MERCURY THERMOMETER, SENITHERM ORAL DISPOSABLE THERMOMETER SHEATHS FOR |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | BANTA HEALTHCARE GROUP, LTD. 570 ENTERPRISE DR. P.O. BOX 806 Neenah, WI 54957 -0806 |
| Contact | Richard Peppard |
| Correspondent | Richard Peppard BANTA HEALTHCARE GROUP, LTD. 570 ENTERPRISE DR. P.O. BOX 806 Neenah, WI 54957 -0806 |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-09-28 |
| Decision Date | 1998-10-19 |
| Summary: | summary |