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FDA 510(k)

ALCOHOL PREP AND POVIDONE-IODINE PREP

K-Number: K896835 · 1990-01-11

ApplicantNorpak Mfg., Inc.
Decision Date1990-01-11
Product CodeLKB
DecisionSubstantially Equivalent

Device Summary

ALCOHOL PREP AND POVIDONE-IODINE PREP is the device name listed in this FDA 510(k) record. The listed applicant is Norpak Mfg., Inc.. It received FDA 510(k) clearance on 1990-01-11 under 510(k) number K896835. The device is classified under product code LKB. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ALCOHOL PREP AND POVIDONE-IODINE PREP?

ALCOHOL PREP AND POVIDONE-IODINE PREP is a medical device that received FDA 510(k) clearance on 1990-01-11. The listed applicant is Norpak Mfg., Inc.. The 510(k) number is K896835.

When did ALCOHOL PREP AND POVIDONE-IODINE PREP receive FDA 510(k) clearance?

ALCOHOL PREP AND POVIDONE-IODINE PREP received FDA 510(k) clearance on 1990-01-11, under 510(k) number K896835.

Who is the listed applicant for ALCOHOL PREP AND POVIDONE-IODINE PREP?

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

What is the FDA product code for ALCOHOL PREP AND POVIDONE-IODINE PREP?

The FDA product code for ALCOHOL PREP AND POVIDONE-IODINE PREP is LKB.

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 Norpak Mfg., Inc. 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.

K934347ANTIFOG

Related Devices (Code: LKB)

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.

K121655BD ALCOHOL SWABBecton, Dickinson & COK112791SITESCRUB IPA DEVICEC. R. BardK912161I.V. STARR KITMedical Device Inspection Co., Inc.K912731STERI-SWABWestlock Investments (Usa), Inc.K910735HEXIDIS ALCOHOL SWABSpecialites SeptodontK896898BOWEN ELECTRODE SKIN PREPATORY CLEANSERBowen & Company, 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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