FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
LORREX HEALTH PRODUCTS - CLINICAL MERCURY THERMOME
K Number: K923225
·
Decision Jun 8, 1993
Classifications
1
FEI Numbers
35
Registration Numbers
35
Same Product Code
32
Applicant Total
16
Review Days
342
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Basic Information
- Device Name
- LORREX HEALTH PRODUCTS - CLINICAL MERCURY THERMOME
- K Number
- K923225
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.2920
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Lorrex Health Products
- Date Received
- July 1, 1992
- Decision Date
- June 8, 1993
- Product Code
- FLK
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| FLK | Thermometer, Clinical Mercury | FDA class 2 | General Hospital |
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Other Clearances by Lorrex Health Products
| K Number | Device Name | ||
|---|---|---|---|
| K945553 | ROUND STICK SPONGES, FLAT STICK SPONGES | Dec 28, 1994 | Substantially Equivalent |
| K945866 | CYLINDRICAL SPONGE | Dec 28, 1994 | Substantially Equivalent |
| K945333 | KITTNER DISSECTOR | Dec 28, 1994 | Substantially Equivalent |
| K945606 | TRIANGULAR SPONGES | Dec 28, 1994 | Substantially Equivalent |
| K945335 | CHERRY DISSECTOR | Dec 28, 1994 | Substantially Equivalent |
| K945334 | CHERRY PIT DISSECTOR | Dec 5, 1994 | Substantially Equivalent |
| K945332 | ROSEBUD DISSECTOR | Dec 5, 1994 | Substantially Equivalent |
| K945336 | PEANUT DISSECTOR | Dec 5, 1994 | Substantially Equivalent |
| K942824 | LORREX IV SPONGES, STERILE 2'S; LORREX DRAIN SPONGES, STERILE 2'S | Aug 3, 1994 | Substantially Equivalent |
| K942314 | LORREX GAUZE SPONGES SPECIALTY | Jun 2, 1994 | Substantially Equivalent |