Disimetric Release of Instranetics Rad
FDA 510(k) K830786 · American Convertors Div., American Pharmaseal
510(k) numberK830786
Submission
- Device name
- Disimetric Release of Instranetics Rad
- Applicant
- American Convertors Div., American Pharmaseal
Mchenry, IL, US - Received
- March 11, 1983
- Decision date
- May 18, 1983
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KOA – Surgical Instruments, G-U, Manual (And Accessories)
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 876.4730
- Specialty
- Gastroenterology, Urology
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| K921228 | Benderev Protect-A-Pass NeedleKOA · Traditional | Eimark Labs, Inc. | 09/14/1992SE |
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| K896058 | Grasping ForcepsKOA · Traditional | Annex Medical, Inc. | 12/28/1989SE |
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| K802919 | Iso-Bac Instrument WrapFRG · Traditional | 02/02/1981SE |
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Questions and answers
When was Disimetric Release of Instranetics Rad cleared by the FDA?
Disimetric Release of Instranetics Rad (K830786) received a 510(k) decision of Substantially Equivalent on May 18, 1983, 68 days after the submission was received.
What is the product code of K830786?
The FDA product code is KOA – Surgical Instruments, G-U, Manual (And Accessories), a Class I (low risk) device regulated under 21 CFR 876.4730.