SUN BED BY VERRE ET QUARTZ UVA-FRANCE
FDA 510(k) clearance K833229 · decided 1984-01-27
Clearance details
- K-number
- K833229
- Device name
- SUN BED BY VERRE ET QUARTZ UVA-FRANCE
- Applicant
- H & M Douglas Enterprises, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1983-08-24
- Decision date
- 1984-01-27
- Days to decision
- 156 days
- Clearance type
- Traditional
- Product code
- FTZ
- Device class
- 1
- Regulation number
- 886.4445
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch H & M Douglas Enterprises
The Builder collects up to 8 candidate devices side by side with yours, then exports the substantial-equivalence comparison scaffold. How it works
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| MODEL 200 (K830468) | Western Laboratories Corp. | 1983-04-12 |
Recalls involving this device
No recalls on record reference this clearance.