REPROCESSED COMPRESSION SLEEVES— 510(k) K100909
Substantially EquivalentAscent Healthcare Solutions
FDA 510(k) clearance K100909 for REPROCESSED COMPRESSION SLEEVES, Substantially Equivalent on 2010-07-23. Applicant: Ascent Healthcare Solutions. Device class: 2.
Clearance details
- Applicant
- Ascent Healthcare Solutions
- Product code
- Code JOW
- Device class
- Class 2
- Regulation
- 21 CFR 870.5800
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Phoenix, AZ, US
Recent devices under product code JOW
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- K100537 — REPROCESSED ULTRASONIC CURVED SHEARS WITH TORQUE WRENCH AND GRIP ASSIST MODEL FCS9, TWBLUE, GABLUE
- K100080 — REPROCESSED TROCARS, MODEL B5LT AND CB5LT
Recalls naming K100909
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K100909.
Data sourced from openFDA. This site is unofficial and independent of the FDA.