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FDA 510(k)

OPPORTUNITY, INC. LACERATION TRAY

K-Number: K971089 · 1997-09-16

ApplicantOpportunity, Inc.
Decision Date1997-09-16
Product CodeKKX
Advisory CommitteeSU
DecisionSubstantially Equivalent for Some Indications

Device Summary

OPPORTUNITY, INC. LACERATION TRAY is the device name listed in this FDA 510(k) record. The listed applicant is Opportunity, Inc.. It received FDA 510(k) clearance on 1997-09-16 under 510(k) number K971089. The device is classified under product code KKX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the OPPORTUNITY, INC. LACERATION TRAY?

OPPORTUNITY, INC. LACERATION TRAY is a medical device that received FDA 510(k) clearance on 1997-09-16. The listed applicant is Opportunity, Inc.. The 510(k) number is K971089.

When did OPPORTUNITY, INC. LACERATION TRAY receive FDA 510(k) clearance?

OPPORTUNITY, INC. LACERATION TRAY received FDA 510(k) clearance on 1997-09-16, under 510(k) number K971089.

Who is the listed applicant for OPPORTUNITY, INC. LACERATION TRAY?

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

What is the FDA product code for OPPORTUNITY, INC. LACERATION TRAY?

The FDA product code for OPPORTUNITY, INC. LACERATION TRAY is KKX.

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Other records listing Opportunity, 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.

K971091OPPURTUNITY TRACHEOSTOMY CARE KITK971088OPPORTUNITY INCISION AND DRAINAGE TRAYK971093OPPORTUNITY I.V. START KITK971090OPPORTUNITY DRESSING CHANGE TRAYK971095OPPORTUNITY SUTURE REMOVAL KITK971061OPPORTUNITY INC. BONE MARROW BIOPSY AND ASPIRATION TRAY

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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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