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FDA 510(k)

MODIFIED MANUFACTURING PROCESS FOR OMIDERM(TM)

K-Number: K874480 · 1988-02-22

ApplicantOmikron Scientific, Ltd.
Decision Date1988-02-22
Product CodeNAD
Advisory CommitteeSU
DecisionSubstantially Equivalent for Some Indications

Device Summary

MODIFIED MANUFACTURING PROCESS FOR OMIDERM(TM) is the device name listed in this FDA 510(k) record. The listed applicant is Omikron Scientific, Ltd.. It received FDA 510(k) clearance on 1988-02-22 under 510(k) number K874480. The device is classified under product code NAD. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the MODIFIED MANUFACTURING PROCESS FOR OMIDERM(TM)?

MODIFIED MANUFACTURING PROCESS FOR OMIDERM(TM) is a medical device that received FDA 510(k) clearance on 1988-02-22. The listed applicant is Omikron Scientific, Ltd.. The 510(k) number is K874480.

When did MODIFIED MANUFACTURING PROCESS FOR OMIDERM(TM) receive FDA 510(k) clearance?

MODIFIED MANUFACTURING PROCESS FOR OMIDERM(TM) received FDA 510(k) clearance on 1988-02-22, under 510(k) number K874480.

Who is the listed applicant for MODIFIED MANUFACTURING PROCESS FOR OMIDERM(TM)?

The FDA 510(k) record lists Omikron Scientific, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MODIFIED MANUFACTURING PROCESS FOR OMIDERM(TM)?

The FDA product code for MODIFIED MANUFACTURING PROCESS FOR OMIDERM(TM) is NAD.

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.

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Other records listing Omikron Scientific, Ltd. 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.

K904445OMIBANDK844277OMIKRON PACEMAKER 837 UNIPOLAR & 838 BIPOLARK840748LITHIUM PACEMAKER 811-811L & 811XL

Related Devices (Code: NAD)

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.

K254246LT Antibacterial Foam with Silver DressingZhejiang Longterm Medical Technology Co., Ltd.K102403SAM CHEST SEAL WITH VAVLE; SAM CHEST SEALSam Medical ProductsK091133APLION TOPICAL CARE SYSTEMAplion Medical,LlcK072560ENVELA (HYDROHESIVE OCCLUSIVE DRESSING)Teikoku Pharma USA, Inc.K080524CENTURION SORBAVIEW OTCTri-State Hospital Supply Corp.K060046DERMASTREAMEnzysurge , Ltd.

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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