The following data is part of a premarket notification filed by Kang Ze Industrial Co. Limited with the FDA for Disposable Thermometer Covers And Sheaths.
| Device ID | K112289 |
| 510k Number | K112289 |
| Device Name: | DISPOSABLE THERMOMETER COVERS AND SHEATHS |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | KANG ZE INDUSTRIAL CO. LIMITED RM 1706 YUESHA BLDG NO 128 SONGLE RD Songjiang Area, Shanghai, CN 201600 |
| Contact | Doris Dong |
| Correspondent | Doris Dong KANG ZE INDUSTRIAL CO. LIMITED RM 1706 YUESHA BLDG NO 128 SONGLE RD Songjiang Area, Shanghai, CN 201600 |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-08-09 |
| Decision Date | 2011-12-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00616784561431 | K112289 | 000 |