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FDA 510(k)

EVERT-IT

K-Number: K962828 · 1997-02-10

ApplicantGenesis Industries, Inc.
Decision Date1997-02-10
Product CodeHGY
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

EVERT-IT is the device name listed in this FDA 510(k) record. The listed applicant is Genesis Industries, Inc.. It received FDA 510(k) clearance on 1997-02-10 under 510(k) number K962828. The device is classified under product code HGY. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EVERT-IT?

EVERT-IT is a medical device that received FDA 510(k) clearance on 1997-02-10. The listed applicant is Genesis Industries, Inc.. The 510(k) number is K962828.

When did EVERT-IT receive FDA 510(k) clearance?

EVERT-IT received FDA 510(k) clearance on 1997-02-10, under 510(k) number K962828.

Who is the listed applicant for EVERT-IT?

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

What is the FDA product code for EVERT-IT?

The FDA product code for EVERT-IT is HGY.

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Other records listing Genesis Industries, Inc. as applicant

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K994361ESP FOUR WELL TISSUE CULTURE PLATE, ESP SIX WELL TISSUE CULTURE PLATE, ESP MICRO SIX WELL TISSUE CULTURE PLATE, ESP WELLK880377NOVO VIVO MODEL #17140 AND #17135K880376NOVO VIVO SUCTION CATHETER VESSEL W/MUCOSE TRAPK833287SATIN CAST ECONOCASTK833290C & B 40 PENTRO C & B40K833278C & B 45

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Related Devices (Code: HGY)

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.

K101538HANDHELD MANUAL BREAST PUMP (AVENT MANUAL BREAST PUMP)Philips Electronics UK LimitedK032845EASY COMFORT DELUXE MANUAL BREAST PUMP, MODEL 1187The First Years, Inc.K013226EVENFLO COMFORT EASE MANUAL BREAST PUMP KITEvenflo Company, Inc.K011519AMEDA HYGIENIKITHollister, Inc.K971231WHITE RIVER MINI MANUAL BREAST PUMPWhite River ConceptsK952034MEDELA'S FOOT PUMPMedela, 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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