LIGHT, EXAMINING, DENTAL, ULTRA VIOLET
FDA 510(k) clearance K770685 · decided 1977-04-26
Clearance details
- K-number
- K770685
- Device name
- LIGHT, EXAMINING, DENTAL, ULTRA VIOLET
- Applicant
- Parker Laboratories, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1977-04-12
- Decision date
- 1977-04-26
- Days to decision
- 14 days
- Clearance type
- Traditional
- Product code
- EAQ
- Device class
- 2
- Regulation number
- 872.6350
- 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 |
|---|---|---|
| SUNSOR ULTRAVIOLET METER (K934728) | Sunsor, Inc. | 1994-07-28 |
Recalls involving this device
No recalls on record reference this clearance.