ELVAREX/ELVAREX SOFT/ELVAREX SOFT SEAMLESS— 510(k) K123561
Substantially EquivalentBsn Medical, Inc.
FDA 510(k) clearance K123561 for ELVAREX/ELVAREX SOFT/ELVAREX SOFT SEAMLESS, Substantially Equivalent on 2012-12-18. Applicant: Bsn Medical, Inc.. Device class: 2.
Clearance details
- Applicant
- Bsn Medical, Inc.
- Product code
- Code DWL
- Device class
- Class 2
- Regulation
- 21 CFR 880.5780
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Rutherford College, NC, US
Recent devices under product code DWL
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- K122485 — ENCIRCLE COMPRESSION THERAPY STOCKING
- K123820 — BOSSONG HOSIERY MEDICAL COMPRESSION STOCKINGS 8-15 MMHG, BOSSONG HOSIERY ANTI-EMBOLISM STOCKINGS 10-20 MMHG, BOSSONG HOS
- K123085 — FUTURO (TM) TRAVEL KNEE-HIGHS; FUTURO (TM) TRAVEL SOCKS; FUTURO (TM) TRAVEL STOCKINGS; FUTURO (TM) TRAVEL PANTYHOSE
Data sourced from openFDA. This site is unofficial and independent of the FDA.