The following data is part of a premarket notification filed by Liaoning-usa Corp. with the FDA for Clinical Thermometer; Rectal/oral, Inner Armpit.
Device ID | K902625 |
510k Number | K902625 |
Device Name: | CLINICAL THERMOMETER; RECTAL/ORAL, INNER ARMPIT |
Classification | Thermometer, Clinical Mercury |
Applicant | LIAONING-USA CORP. 123 WEST BELLEVUE, UNIT#4 Pasadena, CA 91105 -2549 |
Contact | Dorothea Martin |
Correspondent | Dorothea Martin LIAONING-USA CORP. 123 WEST BELLEVUE, UNIT#4 Pasadena, CA 91105 -2549 |
Product Code | FLK |
CFR Regulation Number | 880.2920 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-06-14 |
Decision Date | 1990-10-26 |