SENSATION -VACUUM ASSIST DEVICES— 510(k) K000124
Substantially EquivalentProsurg, Inc.
FDA 510(k) clearance K000124 for SENSATION -VACUUM ASSIST DEVICES, Substantially Equivalent on 2000-07-10. Applicant: Prosurg, Inc.. Device class: 2.
Clearance details
- Applicant
- Prosurg, Inc.
- Product code
- Code LKY
- Device class
- Class 2
- Regulation
- 21 CFR 876.5020
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- San Jose, CA, US
Recent devices under product code LKY
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Data sourced from openFDA. This site is unofficial and independent of the FDA.