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FDA 510(k)

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

K-Number: K131496 · 2013-07-10

ApplicantBsn Medical, Inc.
Decision Date2013-07-10
Product CodeDWL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

BELLAVAR / CUSTOM SEAMLESS SOFT (A.K.A. COMTESSE) 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 2013-07-10 under 510(k) number K131496. 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 BELLAVAR / CUSTOM SEAMLESS SOFT (A.K.A. COMTESSE)?

BELLAVAR / CUSTOM SEAMLESS SOFT (A.K.A. COMTESSE) is a medical device that received FDA 510(k) clearance on 2013-07-10. The listed applicant is Bsn Medical, Inc.. The 510(k) number is K131496.

When did BELLAVAR / CUSTOM SEAMLESS SOFT (A.K.A. COMTESSE) receive FDA 510(k) clearance?

BELLAVAR / CUSTOM SEAMLESS SOFT (A.K.A. COMTESSE) received FDA 510(k) clearance on 2013-07-10, under 510(k) number K131496.

Who is the listed applicant for BELLAVAR / CUSTOM SEAMLESS SOFT (A.K.A. COMTESSE)?

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 BELLAVAR / CUSTOM SEAMLESS SOFT (A.K.A. COMTESSE)?

The FDA product code for BELLAVAR / CUSTOM SEAMLESS SOFT (A.K.A. COMTESSE) is DWL.

Related Clinical Trials

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.

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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.

K123561ELVAREX/ELVAREX SOFT/ELVAREX SOFT SEAMLESS

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.

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 CorporationK123561ELVAREX/ELVAREX SOFT/ELVAREX SOFT SEAMLESSBsn Medical, Inc.K121106TRUFORM 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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