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FDA 510(k)

HEMO-WEDGE

K-Number: K790555 · 1980-01-17

ApplicantParker Laboratories, Inc.
Decision Date1980-01-17
Product CodeDZN
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

HEMO-WEDGE is the device name listed in this FDA 510(k) record. The listed applicant is Parker Laboratories, Inc.. It received FDA 510(k) clearance on 1980-01-17 under 510(k) number K790555. The device is classified under product code DZN. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HEMO-WEDGE?

HEMO-WEDGE is a medical device that received FDA 510(k) clearance on 1980-01-17. The listed applicant is Parker Laboratories, Inc.. The 510(k) number is K790555.

When did HEMO-WEDGE receive FDA 510(k) clearance?

HEMO-WEDGE received FDA 510(k) clearance on 1980-01-17, under 510(k) number K790555.

Who is the listed applicant for HEMO-WEDGE?

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

What is the FDA product code for HEMO-WEDGE?

The FDA product code for HEMO-WEDGE is DZN.

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Related Devices (Code: DZN)

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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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