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FDA 510(k)

HANDI-FOAM

K-Number: K935021 · 1994-04-07

ApplicantMedtec, Inc.
Decision Date1994-04-07
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

HANDI-FOAM is the device name listed in this FDA 510(k) record. The listed applicant is Medtec, Inc.. It received FDA 510(k) clearance on 1994-04-07 under 510(k) number K935021. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HANDI-FOAM?

HANDI-FOAM is a medical device that received FDA 510(k) clearance on 1994-04-07. The listed applicant is Medtec, Inc.. The 510(k) number is K935021.

When did HANDI-FOAM receive FDA 510(k) clearance?

HANDI-FOAM received FDA 510(k) clearance on 1994-04-07, under 510(k) number K935021.

Who is the listed applicant for HANDI-FOAM?

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

What is the FDA product code for HANDI-FOAM?

The FDA product code for HANDI-FOAM is IYE.

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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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