The following data is part of a premarket notification filed by Perlink Usa, Inc. with the FDA for Thermometer, Mercury/clinical.
Device ID | K901790 |
510k Number | K901790 |
Device Name: | THERMOMETER, MERCURY/CLINICAL |
Classification | Thermometer, Clinical Mercury |
Applicant | PERLINK USA, INC. 290 STULYVESANT AVE. Rye, NY 10580 |
Contact | S. K Kanwar |
Correspondent | S. K Kanwar PERLINK USA, INC. 290 STULYVESANT AVE. Rye, NY 10580 |
Product Code | FLK |
CFR Regulation Number | 880.2920 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-04-19 |
Decision Date | 1990-07-11 |