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FDA 510(k)

SURGICAL DRAPE WITH AAMI LIQUID BARRIER LEVEL IV

K-Number: K121919 · 2013-02-14

ApplicantExact Medical Manufacturing, Inc.
Decision Date2013-02-14
Product CodeKKX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SURGICAL DRAPE WITH AAMI LIQUID BARRIER LEVEL IV is the device name listed in this FDA 510(k) record. The listed applicant is Exact Medical Manufacturing, Inc.. It received FDA 510(k) clearance on 2013-02-14 under 510(k) number K121919. 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 SURGICAL DRAPE WITH AAMI LIQUID BARRIER LEVEL IV?

SURGICAL DRAPE WITH AAMI LIQUID BARRIER LEVEL IV is a medical device that received FDA 510(k) clearance on 2013-02-14. The listed applicant is Exact Medical Manufacturing, Inc.. The 510(k) number is K121919.

When did SURGICAL DRAPE WITH AAMI LIQUID BARRIER LEVEL IV receive FDA 510(k) clearance?

SURGICAL DRAPE WITH AAMI LIQUID BARRIER LEVEL IV received FDA 510(k) clearance on 2013-02-14, under 510(k) number K121919.

Who is the listed applicant for SURGICAL DRAPE WITH AAMI LIQUID BARRIER LEVEL IV?

The FDA 510(k) record lists Exact Medical Manufacturing, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SURGICAL DRAPE WITH AAMI LIQUID BARRIER LEVEL IV?

The FDA product code for SURGICAL DRAPE WITH AAMI LIQUID BARRIER LEVEL IV is KKX.

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Other records listing Exact Medical Manufacturing, 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.

K120045EMM HIGH PERFORMANCE SURGICAL GOWN WITH AAMI LIQUID BARRIER LEVEL IVK111535EMM SURGICAL GOWN - SPUNLACE WITH PE LAYERK101598EMM SURGICAL DRAPE SMS W/PE SIDES MODEL 13-005 (WITH MINOR DIMENSIONAL VARIATIONS FOR ALTERNATE CONFIGURATIONS)K101689EMM EQUIPMENT COVER-POLYTHYLENEK101688EMM SURGICAL DRAPE-SPUNLACE W/PE SIDES, MODEL 13-004K101593EMM SURGICAL GOWN-SMS WITH PE LAYER, MODEL 18-501 L, 18-501-XL, 18-501 XXL, 18-501-XLXL

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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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