SUPERLITE PENLIGHT
FDA 510(k) clearance K861028 · decided 1986-04-04
Clearance details
- K-number
- K861028
- Device name
- SUPERLITE PENLIGHT
- Applicant
- Keta Corp.
- Decision
- Substantially Equivalent
- Date received
- 1986-03-18
- Decision date
- 1986-04-04
- Days to decision
- 17 days
- Clearance type
- Traditional
- Advisory committee
- Unknown
- Location
- Danvers, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.