PREGELLED DISPOS. ELECTRODE,SILVER-SILVER CHLORIDE
FDA 510(k) clearance K865090 · decided 1987-02-19
Clearance details
- K-number
- K865090
- Device name
- PREGELLED DISPOS. ELECTRODE,SILVER-SILVER CHLORIDE
- Applicant
- Labeltape Meditect, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1986-12-30
- Decision date
- 1987-02-19
- Days to decision
- 51 days
- Clearance type
- Traditional
- Advisory committee
- Unknown
- Location
- Grand Rapids, MI, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.