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FDA 510(k)

CLEARSITE HYDROGEL WOUND DRESSING MODIFICATION

K-Number: K920677 · 1992-04-21

ApplicantNew Dimensions IN Medicine, Inc.
Decision Date1992-04-21
Product CodeNAE
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

CLEARSITE HYDROGEL WOUND DRESSING MODIFICATION is the device name listed in this FDA 510(k) record. The listed applicant is New Dimensions IN Medicine, Inc.. It received FDA 510(k) clearance on 1992-04-21 under 510(k) number K920677. 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 HYDROGEL WOUND DRESSING MODIFICATION?

CLEARSITE HYDROGEL WOUND DRESSING MODIFICATION is a medical device that received FDA 510(k) clearance on 1992-04-21. The listed applicant is New Dimensions IN Medicine, Inc.. The 510(k) number is K920677.

When did CLEARSITE HYDROGEL WOUND DRESSING MODIFICATION receive FDA 510(k) clearance?

CLEARSITE HYDROGEL WOUND DRESSING MODIFICATION received FDA 510(k) clearance on 1992-04-21, under 510(k) number K920677.

Who is the listed applicant for CLEARSITE HYDROGEL WOUND DRESSING MODIFICATION?

The FDA 510(k) record lists New Dimensions IN Medicine, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CLEARSITE HYDROGEL WOUND DRESSING MODIFICATION?

The FDA product code for CLEARSITE HYDROGEL WOUND DRESSING MODIFICATION is NAE.

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Other records listing New Dimensions IN Medicine, 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.

K832145MONOBLOCK PROSTOPERATIVE TENS ELECTRODEK822077RESPIRATION MONITOR TYPE MR-10K780631NDM INFANT ECG PACKPADK780405INFANT ELECTROSURGICAL GROUNDING PADK771749AMALGAM DISPENSER

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

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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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