ES-3840, VIDEO SIGMOIDOSCOPE— 510(k) K961567
Substantially EquivalentPentax Precision Instrument Corp.
FDA 510(k) clearance K961567 for ES-3840, VIDEO SIGMOIDOSCOPE, Substantially Equivalent on 1996-06-24. Applicant: Pentax Precision Instrument Corp.. Device class: 2.
Clearance details
- Applicant
- Pentax Precision Instrument Corp.
- Product code
- Code FAM
- Device class
- Class 2
- Regulation
- 21 CFR 876.1500
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Miramar, FL, US
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More clearances from Pentax Precision Instrument Corp.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.