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FDA 510(k)

VITOP DRESSING

K-Number: K990974 · 1999-06-09

ApplicantWonder & Bioenergy Hi-Tech America, Inc.
Decision Date1999-06-09
Product CodeEFQ
DecisionSubstantially Equivalent

Device Summary

VITOP DRESSING is the device name listed in this FDA 510(k) record. The listed applicant is Wonder & Bioenergy Hi-Tech America, Inc.. It received FDA 510(k) clearance on 1999-06-09 under 510(k) number K990974. The device is classified under product code EFQ. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VITOP DRESSING?

VITOP DRESSING is a medical device that received FDA 510(k) clearance on 1999-06-09. The listed applicant is Wonder & Bioenergy Hi-Tech America, Inc.. The 510(k) number is K990974.

When did VITOP DRESSING receive FDA 510(k) clearance?

VITOP DRESSING received FDA 510(k) clearance on 1999-06-09, under 510(k) number K990974.

Who is the listed applicant for VITOP DRESSING?

The FDA 510(k) record lists Wonder & Bioenergy Hi-Tech America, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VITOP DRESSING?

The FDA product code for VITOP DRESSING is EFQ.

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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.K990584GAUZE SPONGES: LAPAROTOMY SPONGE, X-RAY DETECTABLEBroadline Medical IndustriesK984187CROSSTEX NON-WOVEN SPONGESCrosstex Intl.K983016GAUZE, SPONGES, CAT # 11-003Vitalcare Group, Inc.K983348DYNAREX TRACHEOSTOMY SPONGEDynarex Corp.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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