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FDA 510(k)

ENVINET(TM)

K-Number: K874551 · 1988-01-22

ApplicantMarion Laboratories, Inc.
Decision Date1988-01-22
Product CodeEFQ
DecisionSubstantially Equivalent for Some Indications

Device Summary

ENVINET(TM) is the device name listed in this FDA 510(k) record. The listed applicant is Marion Laboratories, Inc.. It received FDA 510(k) clearance on 1988-01-22 under 510(k) number K874551. The device is classified under product code EFQ. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the ENVINET(TM)?

ENVINET(TM) is a medical device that received FDA 510(k) clearance on 1988-01-22. The listed applicant is Marion Laboratories, Inc.. The 510(k) number is K874551.

When did ENVINET(TM) receive FDA 510(k) clearance?

ENVINET(TM) received FDA 510(k) clearance on 1988-01-22, under 510(k) number K874551.

Who is the listed applicant for ENVINET(TM)?

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

What is the FDA product code for ENVINET(TM)?

The FDA product code for ENVINET(TM) is EFQ.

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Other records listing Marion 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.

K883391POLYMER ADHESIVE BANDAGEK875182MODIFIED LABELING FOR TOXI-LAB THC SCREENK875181MODIFIED LABELING FOR TOXI-LAB BROAD SPECTRUMK874554ENVICLUSIVE (TM)K874552ENVISAN PADK874553ENVISAN PASTE

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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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