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FDA 510(k)

ACCUPAC CUSTOM PACK KERLIX SQUARES

K-Number: K861308 · 1986-05-02

ApplicantGeneva Laboratories, Inc.
Decision Date1986-05-02
Product CodeEFQ
DecisionSubstantially Equivalent

Device Summary

ACCUPAC CUSTOM PACK KERLIX SQUARES is the device name listed in this FDA 510(k) record. The listed applicant is Geneva Laboratories, Inc.. It received FDA 510(k) clearance on 1986-05-02 under 510(k) number K861308. The device is classified under product code EFQ. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACCUPAC CUSTOM PACK KERLIX SQUARES?

ACCUPAC CUSTOM PACK KERLIX SQUARES is a medical device that received FDA 510(k) clearance on 1986-05-02. The listed applicant is Geneva Laboratories, Inc.. The 510(k) number is K861308.

When did ACCUPAC CUSTOM PACK KERLIX SQUARES receive FDA 510(k) clearance?

ACCUPAC CUSTOM PACK KERLIX SQUARES received FDA 510(k) clearance on 1986-05-02, under 510(k) number K861308.

Who is the listed applicant for ACCUPAC CUSTOM PACK KERLIX SQUARES?

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

What is the FDA product code for ACCUPAC CUSTOM PACK KERLIX SQUARES?

The FDA product code for ACCUPAC CUSTOM PACK KERLIX SQUARES is EFQ.

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Other records listing Geneva Laboratories, 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.

K881217GENT-L-KARE STERILE URINARY LEG BAGK881213GENT-L-KARE STERILE URINARY DRAINAGE BAG CENTERK881218GENT-L-KARE CLEANSING ENEMA SETK881216GENT-L-KARE VAGINAL IRRIGATION SETK861219ACCUPAC CUSTOM SKIN SCRUB KITK853265ACCUPAC CUSTOM OPERATING ROOM PROCEDURE-DK876543

View all 13 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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