Dorc Compact Micro Surgical System
FDA 510(k) K830216 · Jedmed Instrument Co.
510(k) numberK830216
Submission
- Device name
- Dorc Compact Micro Surgical System
- Applicant
- Jedmed Instrument Co.
Mchenry, IL, US - Received
- January 24, 1983
- Decision date
- March 9, 1983
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- HQE – Instrument, Vitreous Aspiration And Cutting, Ac-Powered
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 886.4150
- Specialty
- Ophthalmic
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Questions and answers
When was Dorc Compact Micro Surgical System cleared by the FDA?
Dorc Compact Micro Surgical System (K830216) received a 510(k) decision of Substantially Equivalent on March 9, 1983, 44 days after the submission was received.
What is the product code of K830216?
The FDA product code is HQE – Instrument, Vitreous Aspiration And Cutting, Ac-Powered, a Class II (moderate risk) device regulated under 21 CFR 886.4150.