3X Blue Panoramic Loupes 13.5 Working Distance
FDA 510(k) K861749 · Keeler Instruments, Inc.
510(k) numberK861749
Submission
- Device name
- 3X Blue Panoramic Loupes 13.5 Working Distance
- Applicant
- Keeler Instruments, Inc.
Broomall, PA, US - Received
- May 6, 1986
- Decision date
- May 23, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- FSP – Loupe, Diagnostic/Surgical
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4800
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code FSP
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Questions and answers
When was 3X Blue Panoramic Loupes 13.5 Working Distance cleared by the FDA?
3X Blue Panoramic Loupes 13.5 Working Distance (K861749) received a 510(k) decision of Substantially Equivalent on May 23, 1986, 17 days after the submission was received.
What is the product code of K861749?
The FDA product code is FSP – Loupe, Diagnostic/Surgical, a Class I (low risk) device regulated under 21 CFR 878.4800.