LENS SET, MENTOR TRIAL— 510(k) K770389
Substantially EquivalentCodman & Shurtleff, Inc.
FDA 510(k) clearance K770389 for LENS SET, MENTOR TRIAL, Substantially Equivalent on 1977-03-14. Applicant: Codman & Shurtleff, Inc.. Device class: 1.
Clearance details
- Applicant
- Codman & Shurtleff, Inc.
- Product code
- Code HPC
- Device class
- Class 1
- Regulation
- 21 CFR 886.1405
- Advisory panel
- Ophthalmic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
Recent devices under product code HPC
view allMore clearances from Codman & Shurtleff, Inc.
view all- K193380 — CERENOVUS Large Bore Catheter; CERENOVUS Aspiration Tubing Set
- K191237 — CERENOVUS Large Bore Catheter
- K173192 — CereLink ICP Sensor Basic Kit, CereLink ICP Sensor Metal Skull Bolt Kit, CereLink ICP Sensor Plastic Skull Bolt Kit, CereLink ICP Sensor Ventricular Catheter Kit
- K172537 — Codman EDS 3 CSF External Drainage System, Codman EDS 3 CSF External Drainage System Collection Bag
- K172022 — CODMAN Hydrocephalus Valves, Catheters & Accessories (Bundled)
Data sourced from openFDA. This site is unofficial and independent of the FDA.