FDA 510(k)

WET-PREP

K-Number: K961822 · 1996-06-11

Decision Date1996-06-11

Product CodeKLE

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

WET-PREP is the device name listed in this FDA 510(k) record. The listed applicant is Bisco, Inc.. It received FDA 510(k) clearance on 1996-06-11 under 510(k) number K961822. The device is classified under product code KLE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the WET-PREP?

WET-PREP is a medical device that received FDA 510(k) clearance on 1996-06-11. The listed applicant is Bisco, Inc.. The 510(k) number is K961822.

When did WET-PREP receive FDA 510(k) clearance?

WET-PREP received FDA 510(k) clearance on 1996-06-11, under 510(k) number K961822.

Who is the listed applicant for WET-PREP?

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 WET-PREP?

The FDA product code for WET-PREP is KLE.

Other records listing Bisco, Inc. as applicant

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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.