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FDA 510(k)

SURGICAL GOWN/SCRUB/LAPAROTOMY/MAYO STAND/BACK TAB

K-Number: K883424 · 1988-09-06

ApplicantIntera Corp.
Decision Date1988-09-06
Product CodeKKX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SURGICAL GOWN/SCRUB/LAPAROTOMY/MAYO STAND/BACK TAB is the device name listed in this FDA 510(k) record. The listed applicant is Intera Corp.. It received FDA 510(k) clearance on 1988-09-06 under 510(k) number K883424. 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 GOWN/SCRUB/LAPAROTOMY/MAYO STAND/BACK TAB?

SURGICAL GOWN/SCRUB/LAPAROTOMY/MAYO STAND/BACK TAB is a medical device that received FDA 510(k) clearance on 1988-09-06. The listed applicant is Intera Corp.. The 510(k) number is K883424.

When did SURGICAL GOWN/SCRUB/LAPAROTOMY/MAYO STAND/BACK TAB receive FDA 510(k) clearance?

SURGICAL GOWN/SCRUB/LAPAROTOMY/MAYO STAND/BACK TAB received FDA 510(k) clearance on 1988-09-06, under 510(k) number K883424.

Who is the listed applicant for SURGICAL GOWN/SCRUB/LAPAROTOMY/MAYO STAND/BACK TAB?

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

What is the FDA product code for SURGICAL GOWN/SCRUB/LAPAROTOMY/MAYO STAND/BACK TAB?

The FDA product code for SURGICAL GOWN/SCRUB/LAPAROTOMY/MAYO STAND/BACK TAB is KKX.

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Other records listing Intera Corp. 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.

K891686LIB SYSTEM, BABY/ADULT DIAPERK885185INTERA SHIELD AND INTERA UNDERGARMENTK883787REUSABLE ADULT INCONTINENT DIAPERK863732SURGICAL DRAPE & DRAPE ACCESSORIESK862380MATTRESS COVER

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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