BELLAVAR / CUSTOM SEAMLESS SOFT (A.K.A. COMTESSE)— 510(k) K131496

Name: FDA 510(k) clearance K131496
Creator: U.S. Food and Drug Administration
Published: 2013-07-10

Substantially Equivalent

Bsn Medical, Inc.

FDA 510(k) clearance K131496 for BELLAVAR / CUSTOM SEAMLESS SOFT (A.K.A. COMTESSE), Substantially Equivalent on 2013-07-10. 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: 2013-05-23
Decision date: 2013-07-10
Decision: Substantially Equivalent
Clearance type: Special
Location: Rutherford College, NC, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DWL

view all

K141127 — MEDLINE ANTI-EMBOLISM STOCKING2014-08-21
K122485 — ENCIRCLE COMPRESSION THERAPY STOCKING2013-04-23
K123820 — BOSSONG HOSIERY MEDICAL COMPRESSION STOCKINGS 8-15 MMHG, BOSSONG HOSIERY ANTI-EMBOLISM STOCKINGS 10-20 MMHG, BOSSONG HOS2013-04-02
K123085 — FUTURO (TM) TRAVEL KNEE-HIGHS; FUTURO (TM) TRAVEL SOCKS; FUTURO (TM) TRAVEL STOCKINGS; FUTURO (TM) TRAVEL PANTYHOSE2012-12-20
K123398 — DR. SCHOLL'S COMPRESSION SOCKS2012-12-18

More clearances from Bsn Medical, Inc.

view all

K123561 — ELVAREX/ELVAREX SOFT/ELVAREX SOFT SEAMLESS2012-12-18

Data sourced from openFDA. This site is unofficial and independent of the FDA.