Sensomat Sidearm Adapter
FDA 510(k) K790597 · Biochem International, Inc.
510(k) numberK790597
Submission
- Device name
- Sensomat Sidearm Adapter
- Applicant
- Biochem International, Inc.
Mchenry, IL, US - Received
- March 26, 1979
- Decision date
- July 10, 1979
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KGZ – Accessories, Catheter
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4200
- Specialty
- General, Plastic Surgery
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Questions and answers
When was Sensomat Sidearm Adapter cleared by the FDA?
Sensomat Sidearm Adapter (K790597) received a 510(k) decision of Substantially Equivalent on July 10, 1979, 106 days after the submission was received.
What is the product code of K790597?
The FDA product code is KGZ – Accessories, Catheter, a Class I (low risk) device regulated under 21 CFR 878.4200.