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FDA 510(k)

DRAPES, MODESTY

K-Number: K770396 · 1977-03-23

ApplicantMark One Healthcare Products
Decision Date1977-03-23
Product CodeKKX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

DRAPES, MODESTY is the device name listed in this FDA 510(k) record. The listed applicant is Mark One Healthcare Products. It received FDA 510(k) clearance on 1977-03-23 under 510(k) number K770396. 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 DRAPES, MODESTY?

DRAPES, MODESTY is a medical device that received FDA 510(k) clearance on 1977-03-23. The listed applicant is Mark One Healthcare Products. The 510(k) number is K770396.

When did DRAPES, MODESTY receive FDA 510(k) clearance?

DRAPES, MODESTY received FDA 510(k) clearance on 1977-03-23, under 510(k) number K770396.

Who is the listed applicant for DRAPES, MODESTY?

The FDA 510(k) record lists Mark One Healthcare Products as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DRAPES, MODESTY?

The FDA product code for DRAPES, MODESTY is KKX.

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Other records listing Mark One Healthcare Products 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.

K891986MULTIPLE-VARIOUS TYPES OF ABSORBENT INCONTINENCEK833867PAREMA K BAND NON-STERILEK833084MASTERHINGEK761268SKIN PRESSURE PROTECTORS

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

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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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