REPROCESSED COMPRESSION LIMB SLEEVES— 510(k) K012658
Substantially EquivalentSurgical Instruments Service and Savings, Inc.
FDA 510(k) clearance K012658 for REPROCESSED COMPRESSION LIMB SLEEVES, Substantially Equivalent on 2002-05-14. Applicant: Surgical Instruments Service and Savings, Inc.. Device class: 2.
Clearance details
- Applicant
- Surgical Instruments Service and Savings, Inc.
- 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
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Recalls naming K012658
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 K012658.
Data sourced from openFDA. This site is unofficial and independent of the FDA.