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FDA 510(k)

HEMO-DE

K-Number: K822784 · 1982-11-05

ApplicantPmp Industries
Decision Date1982-11-05
Product CodeKEM
Advisory CommitteePA
DecisionSubstantially Equivalent

Device Summary

HEMO-DE is the device name listed in this FDA 510(k) record. The listed applicant is Pmp Industries. It received FDA 510(k) clearance on 1982-11-05 under 510(k) number K822784. The device is classified under product code KEM. It was reviewed by the PA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HEMO-DE?

HEMO-DE is a medical device that received FDA 510(k) clearance on 1982-11-05. The listed applicant is Pmp Industries. The 510(k) number is K822784.

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

HEMO-DE received FDA 510(k) clearance on 1982-11-05, under 510(k) number K822784.

Who is the listed applicant for HEMO-DE?

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

What is the FDA product code for HEMO-DE?

The FDA product code for HEMO-DE is KEM.

Related Devices (Code: KEM)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K881282XYLENEAnatech, Ltd.K874461HEMO-SOLChem Pharm, Inc.K861490PERMACLEAR SOLUTION CAT. NO. 4950Helena LaboratoriesK855109CLEARENE, CLEARING AGENTSurgipath Medical Industries, Inc.K854083XYLENE SUBSTITUTE MONTANTLerner Laboratories, Inc.K853694XYLENE SUBSTITUTELerner Laboratories, Inc.

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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