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FDA 510(k)

WISEBANDS SKIN CLOSURE DEVICE

K-Number: K002315 · 2001-03-15

ApplicantWisebands , Ltd.
Decision Date2001-03-15
Product CodeMKY
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

WISEBANDS SKIN CLOSURE DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Wisebands , Ltd.. It received FDA 510(k) clearance on 2001-03-15 under 510(k) number K002315. The device is classified under product code MKY. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the WISEBANDS SKIN CLOSURE DEVICE?

WISEBANDS SKIN CLOSURE DEVICE is a medical device that received FDA 510(k) clearance on 2001-03-15. The listed applicant is Wisebands , Ltd.. The 510(k) number is K002315.

When did WISEBANDS SKIN CLOSURE DEVICE receive FDA 510(k) clearance?

WISEBANDS SKIN CLOSURE DEVICE received FDA 510(k) clearance on 2001-03-15, under 510(k) number K002315.

Who is the listed applicant for WISEBANDS SKIN CLOSURE DEVICE?

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

What is the FDA product code for WISEBANDS SKIN CLOSURE DEVICE?

The FDA product code for WISEBANDS SKIN CLOSURE DEVICE is MKY.

Related Clinical Trials

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Related Devices (Code: MKY)

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.

K982439PROXIDERM, MODELS TN 460, TN 90 460, BK 460Progressive Surgical Products, Inc.K970439PROXIDERM (D-460,D 90 460,D 180,460, PS 460)Progressive Surgical Products, Inc.K962144PHOENIX ETE TISSUE EXTENSION SYSTEMPhoenix Biomedical Corp.K942425PROXIDERM (TENTATIVE)Progressive Surgical Products, Inc.K942526SURE-CLOSURE II 75MM SKIN STRETCHING SYSTEMLife Medical Sciences, Inc.

Official Source

View on FDA Database →

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

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