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FDA 510(k)

INSUFO-GARD #100-104

K-Number: K930767 · 1994-04-18

ApplicantAcorn Medical, Inc.
Decision Date1994-04-18
Product CodeHIF
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

INSUFO-GARD #100-104 is the device name listed in this FDA 510(k) record. The listed applicant is Acorn Medical, Inc.. It received FDA 510(k) clearance on 1994-04-18 under 510(k) number K930767. The device is classified under product code HIF. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INSUFO-GARD #100-104?

INSUFO-GARD #100-104 is a medical device that received FDA 510(k) clearance on 1994-04-18. The listed applicant is Acorn Medical, Inc.. The 510(k) number is K930767.

When did INSUFO-GARD #100-104 receive FDA 510(k) clearance?

INSUFO-GARD #100-104 received FDA 510(k) clearance on 1994-04-18, under 510(k) number K930767.

Who is the listed applicant for INSUFO-GARD #100-104?

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

What is the FDA product code for INSUFO-GARD #100-104?

The FDA product code for INSUFO-GARD #100-104 is HIF.

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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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