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FDA 510(k)

BISCEM TRANSLUCENT, MODEL D-45011; BISCEM OPAQUE, MODEL D-45012

K-Number: K082449 · 2008-09-25

ApplicantBisco, Inc.
Decision Date2008-09-25
Product CodeEMA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

BISCEM TRANSLUCENT, MODEL D-45011; BISCEM OPAQUE, MODEL D-45012 is the device name listed in this FDA 510(k) record. The listed applicant is Bisco, Inc.. It received FDA 510(k) clearance on 2008-09-25 under 510(k) number K082449. The device is classified under product code EMA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BISCEM TRANSLUCENT, MODEL D-45011; BISCEM OPAQUE, MODEL D-45012?

BISCEM TRANSLUCENT, MODEL D-45011; BISCEM OPAQUE, MODEL D-45012 is a medical device that received FDA 510(k) clearance on 2008-09-25. The listed applicant is Bisco, Inc.. The 510(k) number is K082449.

When did BISCEM TRANSLUCENT, MODEL D-45011; BISCEM OPAQUE, MODEL D-45012 receive FDA 510(k) clearance?

BISCEM TRANSLUCENT, MODEL D-45011; BISCEM OPAQUE, MODEL D-45012 received FDA 510(k) clearance on 2008-09-25, under 510(k) number K082449.

Who is the listed applicant for BISCEM TRANSLUCENT, MODEL D-45011; BISCEM OPAQUE, MODEL D-45012?

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

What is the FDA product code for BISCEM TRANSLUCENT, MODEL D-45011; BISCEM OPAQUE, MODEL D-45012?

The FDA product code for BISCEM TRANSLUCENT, MODEL D-45011; BISCEM OPAQUE, MODEL D-45012 is EMA.

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Related Devices (Code: EMA)

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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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