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FDA 510(k)

ORTH-EVAC(TM) SUCTION HAND BULB MODEL NO. 01-150

K-Number: K910211 · 1991-04-03

ApplicantDeknatel, Inc.
Decision Date1991-04-03
Product CodeCAC
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

ORTH-EVAC(TM) SUCTION HAND BULB MODEL NO. 01-150 is the device name listed in this FDA 510(k) record. The listed applicant is Deknatel, Inc.. It received FDA 510(k) clearance on 1991-04-03 under 510(k) number K910211. The device is classified under product code CAC. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ORTH-EVAC(TM) SUCTION HAND BULB MODEL NO. 01-150?

ORTH-EVAC(TM) SUCTION HAND BULB MODEL NO. 01-150 is a medical device that received FDA 510(k) clearance on 1991-04-03. The listed applicant is Deknatel, Inc.. The 510(k) number is K910211.

When did ORTH-EVAC(TM) SUCTION HAND BULB MODEL NO. 01-150 receive FDA 510(k) clearance?

ORTH-EVAC(TM) SUCTION HAND BULB MODEL NO. 01-150 received FDA 510(k) clearance on 1991-04-03, under 510(k) number K910211.

Who is the listed applicant for ORTH-EVAC(TM) SUCTION HAND BULB MODEL NO. 01-150?

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

What is the FDA product code for ORTH-EVAC(TM) SUCTION HAND BULB MODEL NO. 01-150?

The FDA product code for ORTH-EVAC(TM) SUCTION HAND BULB MODEL NO. 01-150 is CAC.

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Other records listing Deknatel, Inc. as applicant

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Related Devices (Code: CAC)

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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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