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FDA 510(k)

CLEARSITE(R) STERILE WOUND CARE DRESSING

K-Number: K914207 · 1991-10-23

ApplicantNdm Acquisition Corp.
Decision Date1991-10-23
Product CodeNAE
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

CLEARSITE(R) STERILE WOUND CARE DRESSING is the device name listed in this FDA 510(k) record. The listed applicant is Ndm Acquisition Corp.. It received FDA 510(k) clearance on 1991-10-23 under 510(k) number K914207. The device is classified under product code NAE. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CLEARSITE(R) STERILE WOUND CARE DRESSING?

CLEARSITE(R) STERILE WOUND CARE DRESSING is a medical device that received FDA 510(k) clearance on 1991-10-23. The listed applicant is Ndm Acquisition Corp.. The 510(k) number is K914207.

When did CLEARSITE(R) STERILE WOUND CARE DRESSING receive FDA 510(k) clearance?

CLEARSITE(R) STERILE WOUND CARE DRESSING received FDA 510(k) clearance on 1991-10-23, under 510(k) number K914207.

Who is the listed applicant for CLEARSITE(R) STERILE WOUND CARE DRESSING?

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

What is the FDA product code for CLEARSITE(R) STERILE WOUND CARE DRESSING?

The FDA product code for CLEARSITE(R) STERILE WOUND CARE DRESSING is NAE.

Related Clinical Trials

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Other records listing Ndm Acquisition 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.

K943287ACT-ONE ADVANCED COMPRESSION TECHNOLOGY FOOT PUMPK934601NDM HYDROGAUZE WOUND DRESSINGK931457NDM SILVON ECG ELECTRODES

Related Devices (Code: NAE)

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.

K083721MODIFICATION TO ZENIEVARiver'S Edge Pharmaceuticals, LLCK082865MODIFICATION TO ZENIEVAGorbec Pharmaceutical Services, Inc.K073246ZENIEVAGorbec Pharmaceutical Services, Inc.K992094GILTECH PLUS HYDROGEL SKIN DRESSINGGiltech Plus, Inc.K991061DERMAPHYLYX CALCIUM ALGINATE WOUND DRESSINGDermaphylyx, Inc.K972646AD-HEAL HYDROGEL DRESSING, VARIOUS SIZESLudlow Technical Products

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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