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FDA 510(k)

ELVAREX/ELVAREX SOFT/ELVAREX SOFT SEAMLESS

K-Number: K123561 · 2012-12-18

ApplicantBsn Medical, Inc.
Decision Date2012-12-18
Product CodeDWL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

ELVAREX/ELVAREX SOFT/ELVAREX SOFT SEAMLESS is the device name listed in this FDA 510(k) record. The listed applicant is Bsn Medical, Inc.. It received FDA 510(k) clearance on 2012-12-18 under 510(k) number K123561. The device is classified under product code DWL. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ELVAREX/ELVAREX SOFT/ELVAREX SOFT SEAMLESS?

ELVAREX/ELVAREX SOFT/ELVAREX SOFT SEAMLESS is a medical device that received FDA 510(k) clearance on 2012-12-18. The listed applicant is Bsn Medical, Inc.. The 510(k) number is K123561.

When did ELVAREX/ELVAREX SOFT/ELVAREX SOFT SEAMLESS receive FDA 510(k) clearance?

ELVAREX/ELVAREX SOFT/ELVAREX SOFT SEAMLESS received FDA 510(k) clearance on 2012-12-18, under 510(k) number K123561.

Who is the listed applicant for ELVAREX/ELVAREX SOFT/ELVAREX SOFT SEAMLESS?

The FDA 510(k) record lists Bsn Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ELVAREX/ELVAREX SOFT/ELVAREX SOFT SEAMLESS?

The FDA product code for ELVAREX/ELVAREX SOFT/ELVAREX SOFT SEAMLESS is DWL.

Related Clinical Trials

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Other records listing Bsn Medical, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K131496BELLAVAR / CUSTOM SEAMLESS SOFT (A.K.A. COMTESSE)

Related Devices (Code: DWL)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K131496BELLAVAR / CUSTOM SEAMLESS SOFT (A.K.A. COMTESSE)Bsn Medical, Inc.K122485ENCIRCLE COMPRESSION THERAPY STOCKINGEncircle Medical Devices , Ltd.K123820BOSSONG HOSIERY MEDICAL COMPRESSION STOCKINGS 8-15 MMHG, BOSSONG HOSIERY ANTI-EMBOLISM STOCKINGS 10-20 MMHG, BOSSONG HOSBossong Hosiery Mills, Inc.K123085FUTURO (TM) TRAVEL KNEE-HIGHS; FUTURO (TM) TRAVEL SOCKS; FUTURO (TM) TRAVEL STOCKINGS; FUTURO (TM) TRAVEL PANTYHOSE3M CompanyK123398DR. SCHOLL'S COMPRESSION SOCKSRenfro CorporationK121106TRUFORM READY-TO-WEAR COMPRESSION ARM SLEECE TRUFORM READY-TO-WEAR COMPRESSION GAUNTLETSurgical Appliance Industries, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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