Nagashima F60MM Attach. Lens
FDA 510(k) K821705 · Kelleher Corp.
510(k) numberK821705
Submission
- Device name
- Nagashima F60MM Attach. Lens
- Applicant
- Kelleher Corp.
Mchenry, IL, US - Received
- June 9, 1982
- Decision date
- July 9, 1982
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- FXQ – Lens, Camera, Surgical
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4160
- Specialty
- General, Plastic Surgery
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Questions and answers
When was Nagashima F60MM Attach. Lens cleared by the FDA?
Nagashima F60MM Attach. Lens (K821705) received a 510(k) decision of Substantially Equivalent on July 9, 1982, 30 days after the submission was received.
What is the product code of K821705?
The FDA product code is FXQ – Lens, Camera, Surgical, a Class I (low risk) device regulated under 21 CFR 878.4160.