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FDA 510(k)

AQUAFLO HYDROGEL WOUND DRESSING & PACKER

K-Number: K952945 · 1995-08-23

ApplicantSherwood Medical Co.
Decision Date1995-08-23
Product CodeNAE
Advisory CommitteeSU
DecisionSubstantially Equivalent for Some Indications

Device Summary

AQUAFLO HYDROGEL WOUND DRESSING & PACKER is the device name listed in this FDA 510(k) record. The listed applicant is Sherwood Medical Co.. It received FDA 510(k) clearance on 1995-08-23 under 510(k) number K952945. The device is classified under product code NAE. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the AQUAFLO HYDROGEL WOUND DRESSING & PACKER?

AQUAFLO HYDROGEL WOUND DRESSING & PACKER is a medical device that received FDA 510(k) clearance on 1995-08-23. The listed applicant is Sherwood Medical Co.. The 510(k) number is K952945.

When did AQUAFLO HYDROGEL WOUND DRESSING & PACKER receive FDA 510(k) clearance?

AQUAFLO HYDROGEL WOUND DRESSING & PACKER received FDA 510(k) clearance on 1995-08-23, under 510(k) number K952945.

Who is the listed applicant for AQUAFLO HYDROGEL WOUND DRESSING & PACKER?

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

What is the FDA product code for AQUAFLO HYDROGEL WOUND DRESSING & PACKER?

The FDA product code for AQUAFLO HYDROGEL WOUND DRESSING & PACKER is NAE.

Related Clinical Trials

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Other records listing Sherwood Medical Co. 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.

K981365MAHURKAR 13.5 FR CUFFED CATHETER WITH CURVED EXTENSIONSK960982MONOJECT BLUNT I.V. ACCESS CANNULA/MONOJECT HYPODERMIC SYRINGE WITH BLUNT I.V. ACCESS CANNULAK962880SENSI-TOUCH COMBO SPINAL/EPIDURAL REGIONAL ANESTHESIA DELIVERY SYSTEMK960574ARGYLE TURKEL NEONATAL/PEDIATRIC THORACIC CATHETER INSERTION TRAY AND THORACIC CATHETER SYSTEMK960677KANGAROO JEJUNAL FEEDING SYSTEMK960632KANGAROO FEEDING TUBE PLACMENT STYLET

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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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