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FDA 510(k)

OPPORTUNITY SUTURE REMOVAL KIT

K-Number: K971095 · 1997-09-16

ApplicantOpportunity, Inc.
Decision Date1997-09-16
Product CodeEFQ
DecisionSubstantially Equivalent for Some Indications

Device Summary

OPPORTUNITY SUTURE REMOVAL KIT 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 K971095. The device is classified under product code EFQ. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the OPPORTUNITY SUTURE REMOVAL KIT?

OPPORTUNITY SUTURE REMOVAL KIT 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 K971095.

When did OPPORTUNITY SUTURE REMOVAL KIT receive FDA 510(k) clearance?

OPPORTUNITY SUTURE REMOVAL KIT received FDA 510(k) clearance on 1997-09-16, under 510(k) number K971095.

Who is the listed applicant for OPPORTUNITY SUTURE REMOVAL KIT?

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 SUTURE REMOVAL KIT?

The FDA product code for OPPORTUNITY SUTURE REMOVAL KIT is EFQ.

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 TRAYK971061OPPORTUNITY INC. BONE MARROW BIOPSY AND ASPIRATION TRAY

View all 8 devices →

Related Devices (Code: EFQ)

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.

K991757NON-ABSORBABLE GAUZE FOR EXTERNAL USE, STERILE AND NON STERILEFurlong IndustriesK991215SYMTEX GAUZE PADS (1'S) AND SYMTEX GAUZE SPONGES STERILE 2'S AND STERILE 10'SSymtex Healthcare Corp.K990974VITOP DRESSINGWonder & Bioenergy Hi-Tech America, Inc.K990584GAUZE SPONGES: LAPAROTOMY SPONGE, X-RAY DETECTABLEBroadline Medical IndustriesK984187CROSSTEX NON-WOVEN SPONGESCrosstex Intl.K983016GAUZE, SPONGES, CAT # 11-003Vitalcare Group, Inc.

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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