The following data is part of a premarket notification filed by Abel Industries, Inc. with the FDA for Mercury Thermometers (oral And Rectal).
| Device ID | K900646 |
| 510k Number | K900646 |
| Device Name: | MERCURY THERMOMETERS (ORAL AND RECTAL) |
| Classification | Thermometer, Clinical Mercury |
| Applicant | ABEL INDUSTRIES, INC. 109 HIGHLAND AVE. Needham, MA 02194 |
| Contact | Marvin Maltz |
| Correspondent | Marvin Maltz ABEL INDUSTRIES, INC. 109 HIGHLAND AVE. Needham, MA 02194 |
| Product Code | FLK |
| CFR Regulation Number | 880.2920 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-02-09 |
| Decision Date | 1990-07-11 |