ENDO L 300 LIGHT, ILLUMINATING WOUND RECTRACTOR
FDA 510(k) clearance K853460 · decided 1985-09-05
Clearance details
- K-number
- K853460
- Device name
- ENDO L 300 LIGHT, ILLUMINATING WOUND RECTRACTOR
- Applicant
- Heraeus, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1985-08-19
- Decision date
- 1985-09-05
- Days to decision
- 17 days
- Clearance type
- Traditional
- Advisory committee
- Unknown
- Location
- West Conshohocken, PA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.