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FDA 510(k)

CONFORM SHEETING, MODEL IGEL

K-Number: K012419 · 2001-10-24

ApplicantImplantech Associates, Inc.
Decision Date2001-10-24
Product CodeMDA
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

CONFORM SHEETING, MODEL IGEL is the device name listed in this FDA 510(k) record. The listed applicant is Implantech Associates, Inc.. It received FDA 510(k) clearance on 2001-10-24 under 510(k) number K012419. The device is classified under product code MDA. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CONFORM SHEETING, MODEL IGEL?

CONFORM SHEETING, MODEL IGEL is a medical device that received FDA 510(k) clearance on 2001-10-24. The listed applicant is Implantech Associates, Inc.. The 510(k) number is K012419.

When did CONFORM SHEETING, MODEL IGEL receive FDA 510(k) clearance?

CONFORM SHEETING, MODEL IGEL received FDA 510(k) clearance on 2001-10-24, under 510(k) number K012419.

Who is the listed applicant for CONFORM SHEETING, MODEL IGEL?

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

What is the FDA product code for CONFORM SHEETING, MODEL IGEL?

The FDA product code for CONFORM SHEETING, MODEL IGEL is MDA.

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Other records listing Implantech Associates, Inc. as applicant

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Related Devices (Code: MDA)

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K112131NEODYNE DRESSINGNeodyne Biosciences, Inc.K111733CORELEADER SCAR-DIMMERCoreleader Biotech Co., Ltd.K083718BEAU RX SCAR CARE GELBeau RX Solutions, LLCK053481KELO-COTE SPRAYAdvanced Bio-Technologies, Inc.K041704NEWGEL AND NEWGEL PLUS ENewmedical Technology, Inc.K040307HANSON SCAR ADEHanson Medical, 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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