PRECIOUS LITE MODEL 4224
FDA 510(k) clearance K892940 · decided 1989-08-03
Clearance details
- K-number
- K892940
- Device name
- PRECIOUS LITE MODEL 4224
- Applicant
- E & B Technologies, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1989-04-21
- Decision date
- 1989-08-03
- Days to decision
- 104 days
- Clearance type
- Traditional
- Product code
- LBI
- Device class
- 2
- Regulation number
- 880.5700
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Oceanside, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.