Pentax LH-150F Light Source
FDA 510(k) K771739 · Pilling Co.
510(k) numberK771739
Submission
- Device name
- Pentax LH-150F Light Source
- Applicant
- Pilling Co.
Mchenry, IL, US - Received
- September 15, 1977
- Decision date
- September 30, 1977
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- FCW – Light Source, Fiberoptic, Routine
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Specialty
- Gastroenterology, Urology
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Questions and answers
When was Pentax LH-150F Light Source cleared by the FDA?
Pentax LH-150F Light Source (K771739) received a 510(k) decision of Substantially Equivalent on September 30, 1977, 15 days after the submission was received.
What is the product code of K771739?
The FDA product code is FCW – Light Source, Fiberoptic, Routine, a Class II (moderate risk) device regulated under 21 CFR 876.1500.