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FDA 510(k)

STERILE DRESSING PACK

K-Number: K800490 · 1980-03-12

ApplicantMedi-Spec
Decision Date1980-03-12
Product CodeKKX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

STERILE DRESSING PACK is the device name listed in this FDA 510(k) record. The listed applicant is Medi-Spec. It received FDA 510(k) clearance on 1980-03-12 under 510(k) number K800490. The device is classified under product code KKX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STERILE DRESSING PACK?

STERILE DRESSING PACK is a medical device that received FDA 510(k) clearance on 1980-03-12. The listed applicant is Medi-Spec. The 510(k) number is K800490.

When did STERILE DRESSING PACK receive FDA 510(k) clearance?

STERILE DRESSING PACK received FDA 510(k) clearance on 1980-03-12, under 510(k) number K800490.

Who is the listed applicant for STERILE DRESSING PACK?

The FDA 510(k) record lists Medi-Spec as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for STERILE DRESSING PACK?

The FDA product code for STERILE DRESSING PACK is KKX.

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Other records listing Medi-Spec 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.

K833068LAMINARIA JAPONICA CERVICAL DILATORK812694WHISK-RK812426UTERINE ASPIRATION CURETTES(RIGID&FLEX)K801554STERILE CAST PADDINGK800404MEDSPEC OPERATIVE OPTHALMIC KITK790952CLAMP COVERS

View all 8 devices →

Related Devices (Code: KKX)

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.

K230645BeneHold™ Surgical Incise Drape with CHG antimicrobial IIAvery Dennison Medical , Ltd.K2225783M™ Ioban™ CHG Chlorhexidine Gluconate Incise Drape (contains 2% w/w CHG)3M CompanyK202208BeneHold Surgical Incise Drape with CHG antimicrobialAvery Dennison Belgie BvbaK200238ControlRad Sterile CoverControlrad, Inc.K163556MediClear PreOpCovalontechnologies, Inc.K130404TIBURON SURGICAL DRAPECardinal Health200, LLC

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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