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FDA 510(k)

INTERLABIAL PAD

K-Number: K881384 · 1989-02-09

ApplicantXtramedics, Inc.
Decision Date1989-02-09
Product CodeHEB
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

INTERLABIAL PAD is the device name listed in this FDA 510(k) record. The listed applicant is Xtramedics, Inc.. It received FDA 510(k) clearance on 1989-02-09 under 510(k) number K881384. The device is classified under product code HEB. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INTERLABIAL PAD?

INTERLABIAL PAD is a medical device that received FDA 510(k) clearance on 1989-02-09. The listed applicant is Xtramedics, Inc.. The 510(k) number is K881384.

When did INTERLABIAL PAD receive FDA 510(k) clearance?

INTERLABIAL PAD received FDA 510(k) clearance on 1989-02-09, under 510(k) number K881384.

Who is the listed applicant for INTERLABIAL PAD?

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

What is the FDA product code for INTERLABIAL PAD?

The FDA product code for INTERLABIAL PAD is HEB.

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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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