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FDA 510(k)

DISP. FENESTRATED SURG. DRAPE SHEETS

K-Number: K802359 · 1980-10-31

ApplicantAmerican Convertors Div., American Pharmaseal
Decision Date1980-10-31
Product CodeKKX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

DISP. FENESTRATED SURG. DRAPE SHEETS is the device name listed in this FDA 510(k) record. The listed applicant is American Convertors Div., American Pharmaseal. It received FDA 510(k) clearance on 1980-10-31 under 510(k) number K802359. 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 DISP. FENESTRATED SURG. DRAPE SHEETS?

DISP. FENESTRATED SURG. DRAPE SHEETS is a medical device that received FDA 510(k) clearance on 1980-10-31. The listed applicant is American Convertors Div., American Pharmaseal. The 510(k) number is K802359.

When did DISP. FENESTRATED SURG. DRAPE SHEETS receive FDA 510(k) clearance?

DISP. FENESTRATED SURG. DRAPE SHEETS received FDA 510(k) clearance on 1980-10-31, under 510(k) number K802359.

Who is the listed applicant for DISP. FENESTRATED SURG. DRAPE SHEETS?

The FDA 510(k) record lists American Convertors Div., American Pharmaseal as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DISP. FENESTRATED SURG. DRAPE SHEETS?

The FDA product code for DISP. FENESTRATED SURG. DRAPE SHEETS is KKX.

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Other records listing American Convertors Div., American Pharmaseal 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.

K840957ANTIMICROBIAL INCISE DRAPEK832137CONVERTORS FLASH STERILIZING TRAYK830786DISIMETRIC RELEASE OF INSTRANETICS RADK820994ABSORB FURN SHEETK813419COMFORT CUSHION DRY BURN PAD IIIK813296CONVERTORS STERILE DISP. LAP SPONGE II

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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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