The following data is part of a premarket notification filed by Steridyne Corp. with the FDA for Mercury And Glass Fever Thermometer.
Device ID | K911269 |
510k Number | K911269 |
Device Name: | MERCURY AND GLASS FEVER THERMOMETER |
Classification | Thermometer, Clinical Mercury |
Applicant | STERIDYNE CORP. 3725 INVESTMENT LN. Riviera Beach, FL 33404 |
Contact | Mark P Poncy |
Correspondent | Mark P Poncy STERIDYNE CORP. 3725 INVESTMENT LN. Riviera Beach, FL 33404 |
Product Code | FLK |
CFR Regulation Number | 880.2920 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-03-22 |
Decision Date | 1991-05-15 |