FOCUS FLUID
FDA 510(k) clearance K830187 · decided 1983-03-01
Clearance details
- K-number
- K830187
- Device name
- FOCUS FLUID
- Applicant
- Hematology Marketing Assoc.
- Decision
- Substantially Equivalent
- Date received
- 1983-01-19
- Decision date
- 1983-03-01
- Days to decision
- 41 days
- Clearance type
- Traditional
- Product code
- EIF
- Device class
- 1
- Regulation number
- 872.4565
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| MOUTH PROPS (K940785) | Worldwide Dental, Inc. | 1994-10-05 |
| LEWIS SAFE SLEEVE (K873960) | Cheri Lewis, D.D.S. | 1987-12-04 |
| SULCARINGS (K830116) | North Pacific Dental, Inc. | 1983-02-18 |
Recalls involving this device
No recalls on record reference this clearance.