SILICONE ELASTOMER INFUSION CATHETER— 510(k) K813606
Substantially EquivalentQuest Medical, Inc.
FDA 510(k) clearance K813606 for SILICONE ELASTOMER INFUSION CATHETER, Substantially Equivalent on 1982-01-18. Applicant: Quest Medical, Inc.. Device class: 1.
Clearance details
- Applicant
- Quest Medical, Inc.
- Product code
- Code JCY
- Device class
- Class 1
- Regulation
- 21 CFR 878.4200
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
Recent devices under product code JCY
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