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FDA 510(k)

OPPORTUNITY INC. GENERAL PURPOSE TRAY

K-Number: K971062 · 1997-06-09

ApplicantOpportunity, Inc.
Decision Date1997-06-09
Product CodeLRO
Advisory CommitteeSU
DecisionSubstantially Equivalent for Some Indications

Device Summary

OPPORTUNITY INC. GENERAL PURPOSE 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 1997-06-09 under 510(k) number K971062. The device is classified under product code LRO. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the OPPORTUNITY INC. GENERAL PURPOSE TRAY?

OPPORTUNITY INC. GENERAL PURPOSE TRAY is a medical device that received FDA 510(k) clearance on 1997-06-09. The listed applicant is Opportunity, Inc.. The 510(k) number is K971062.

When did OPPORTUNITY INC. GENERAL PURPOSE TRAY receive FDA 510(k) clearance?

OPPORTUNITY INC. GENERAL PURPOSE TRAY received FDA 510(k) clearance on 1997-06-09, under 510(k) number K971062.

Who is the listed applicant for OPPORTUNITY INC. GENERAL PURPOSE 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. GENERAL PURPOSE TRAY?

The FDA product code for OPPORTUNITY INC. GENERAL PURPOSE TRAY is LRO.

Related Clinical Trials

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.

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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 KITK971089OPPORTUNITY, INC. LACERATION TRAYK971088OPPORTUNITY INCISION AND DRAINAGE TRAYK971093OPPORTUNITY I.V. START KITK971090OPPORTUNITY DRESSING CHANGE TRAYK971095OPPORTUNITY SUTURE REMOVAL KIT

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Related Devices (Code: LRO)

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.

K213481Medline General Surgery TrayMedline Industries, Inc.K212258Medline Cardiovascular Procedure KitMedline Industries, Inc.K041080SURGICAL DRAPE KIT - D.I.R.R.A. SRLD.I.R.R.A. S.R.L.K030721QUICK-TAP PARACENTESIS TRAY, KIT & NEEDLEBallard Medical ProductsK023276AMSINO TRACHEOSTOMY CARE TRAYAmsino International, Inc.K980137WORLDWIDE MEDICAL TECHNOLOGIES BONE MARROW BIOPSY PROCEDURE TRAYWorldwide Medical Technologies, 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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