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FDA 510(k)

KLENZYME

K-Number: K944950 · 1994-12-20

ApplicantCalgon Corp.
Decision Date1994-12-20
Product CodeFLG
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

KLENZYME is the device name listed in this FDA 510(k) record. The listed applicant is Calgon Corp.. It received FDA 510(k) clearance on 1994-12-20 under 510(k) number K944950. The device is classified under product code FLG. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KLENZYME?

KLENZYME is a medical device that received FDA 510(k) clearance on 1994-12-20. The listed applicant is Calgon Corp.. The 510(k) number is K944950.

When did KLENZYME receive FDA 510(k) clearance?

KLENZYME received FDA 510(k) clearance on 1994-12-20, under 510(k) number K944950.

Who is the listed applicant for KLENZYME?

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

What is the FDA product code for KLENZYME?

The FDA product code for KLENZYME is FLG.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Calgon Corp. as applicant

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.

K943364CORASSIST WOUND DRESSINGK940263NPH-KLENZK935063INSTRU KLENZK940407KALTOGEL WOUND DRESSING

Related Devices (Code: FLG)

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.

K944494ALSA-KLENZCalgon Vestal Div.K944033BILL EVANS-KLENZCalgon Vestal Div.K940263NPH-KLENZCalgon Corp.K941163MON-KLENZCalgon Vestal Div.K935063INSTRU KLENZCalgon Corp.K934666PDS ULTRACLEANMedical Polymers, Inc.

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.

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