The following data is part of a premarket notification filed by Smith & Nephew United, Inc. with the FDA for Glass Mercury Filled Thermometers.
Device ID | K893602 |
510k Number | K893602 |
Device Name: | GLASS MERCURY FILLED THERMOMETERS |
Classification | Thermometer, Clinical Mercury |
Applicant | SMITH & NEPHEW UNITED, INC. 11775 STARKLEY RD. P.O.BOX 1970 Largo, FL 34649 -1970 |
Contact | Jim Irvin |
Correspondent | Jim Irvin SMITH & NEPHEW UNITED, INC. 11775 STARKLEY RD. P.O.BOX 1970 Largo, FL 34649 -1970 |
Product Code | FLK |
CFR Regulation Number | 880.2920 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-05-15 |
Decision Date | 1989-08-08 |