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FDA 510(k)

KEVTEK(TM) LASER DRAPE/ORGAN PROTECTOR/EYE SHIELD

K-Number: K902000 · 1990-08-21

ApplicantKevtek Medical Products, Inc.
Decision Date1990-08-21
Product CodeFZS
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

KEVTEK(TM) LASER DRAPE/ORGAN PROTECTOR/EYE SHIELD is the device name listed in this FDA 510(k) record. The listed applicant is Kevtek Medical Products, Inc.. It received FDA 510(k) clearance on 1990-08-21 under 510(k) number K902000. The device is classified under product code FZS. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KEVTEK(TM) LASER DRAPE/ORGAN PROTECTOR/EYE SHIELD?

KEVTEK(TM) LASER DRAPE/ORGAN PROTECTOR/EYE SHIELD is a medical device that received FDA 510(k) clearance on 1990-08-21. The listed applicant is Kevtek Medical Products, Inc.. The 510(k) number is K902000.

When did KEVTEK(TM) LASER DRAPE/ORGAN PROTECTOR/EYE SHIELD receive FDA 510(k) clearance?

KEVTEK(TM) LASER DRAPE/ORGAN PROTECTOR/EYE SHIELD received FDA 510(k) clearance on 1990-08-21, under 510(k) number K902000.

Who is the listed applicant for KEVTEK(TM) LASER DRAPE/ORGAN PROTECTOR/EYE SHIELD?

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

What is the FDA product code for KEVTEK(TM) LASER DRAPE/ORGAN PROTECTOR/EYE SHIELD?

The FDA product code for KEVTEK(TM) LASER DRAPE/ORGAN PROTECTOR/EYE SHIELD is FZS.

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 Kevtek Medical Products, 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.

K902193KEVTEK LASER-STOP ENDOTRACHEAL TUBE LASER-STOP

Related Devices (Code: FZS)

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.

K932493SURGICAL CURETTEWhitney Products, Inc.K892521CYMED MICROSKIN(R) DISPOSABLE IRRIGATION SLEEVECymed, Inc.K891888CURRETTES - PIFFARD, WOLF, VIDAL-SCRAPERZinnanti Surgical Instruments, Inc.K891334ACU-CURETTEAcuderm, Inc.K890366ADENOID CURETTEKinetic Medical ProductsK875292MICRODISCECTOMY CURETTE SETT. Korossurgical Instruments 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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