FDA 510(k)

ASSISTED HATCHING MICROPIPETTES, DENUDING PIPETTES, HOLDING MICROPIPETTES, ICSI MICROPIPETTES, PARTIAL ZONE DISSECTION M

K-Number: K991388 · 1999-09-13

Decision Date1999-09-13

Product CodeMQH

Advisory CommitteeOB

DecisionSubstantially Equivalent

Device Summary

ASSISTED HATCHING MICROPIPETTES, DENUDING PIPETTES, HOLDING MICROPIPETTES, ICSI MICROPIPETTES, PARTIAL ZONE DISSECTION M is the device name listed in this FDA 510(k) record. The listed applicant is Pacific Andrology, Inc.. It received FDA 510(k) clearance on 1999-09-13 under 510(k) number K991388. The device is classified under product code MQH. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ASSISTED HATCHING MICROPIPETTES, DENUDING PIPETTES, HOLDING MICROPIPETTES, ICSI MICROPIPETTES, PARTIAL ZONE DISSECTION M?

ASSISTED HATCHING MICROPIPETTES, DENUDING PIPETTES, HOLDING MICROPIPETTES, ICSI MICROPIPETTES, PARTIAL ZONE DISSECTION M is a medical device that received FDA 510(k) clearance on 1999-09-13. The listed applicant is Pacific Andrology, Inc.. The 510(k) number is K991388.

When did ASSISTED HATCHING MICROPIPETTES, DENUDING PIPETTES, HOLDING MICROPIPETTES, ICSI MICROPIPETTES, PARTIAL ZONE DISSECTION M receive FDA 510(k) clearance?

ASSISTED HATCHING MICROPIPETTES, DENUDING PIPETTES, HOLDING MICROPIPETTES, ICSI MICROPIPETTES, PARTIAL ZONE DISSECTION M received FDA 510(k) clearance on 1999-09-13, under 510(k) number K991388.

Who is the listed applicant for ASSISTED HATCHING MICROPIPETTES, DENUDING PIPETTES, HOLDING MICROPIPETTES, ICSI MICROPIPETTES, PARTIAL ZONE DISSECTION M?

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

What is the FDA product code for ASSISTED HATCHING MICROPIPETTES, DENUDING PIPETTES, HOLDING MICROPIPETTES, ICSI MICROPIPETTES, PARTIAL ZONE DISSECTION M?

The FDA product code for ASSISTED HATCHING MICROPIPETTES, DENUDING PIPETTES, HOLDING MICROPIPETTES, ICSI MICROPIPETTES, PARTIAL ZONE DISSECTION M is MQH.

Related Clinical Trials

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Other records listing Pacific Andrology, Inc. as applicant

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Related Devices (Code: MQH)

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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.