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FDA 510(k)

SHARPLAN SERIES 2900 SYNTHETIC CONTACT TIPS

K-Number: K894211 · 1989-08-10

ApplicantSharplan Lasers, Inc.
Decision Date1989-08-10
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SHARPLAN SERIES 2900 SYNTHETIC CONTACT TIPS is the device name listed in this FDA 510(k) record. The listed applicant is Sharplan Lasers, Inc.. It received FDA 510(k) clearance on 1989-08-10 under 510(k) number K894211. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SHARPLAN SERIES 2900 SYNTHETIC CONTACT TIPS?

SHARPLAN SERIES 2900 SYNTHETIC CONTACT TIPS is a medical device that received FDA 510(k) clearance on 1989-08-10. The listed applicant is Sharplan Lasers, Inc.. The 510(k) number is K894211.

When did SHARPLAN SERIES 2900 SYNTHETIC CONTACT TIPS receive FDA 510(k) clearance?

SHARPLAN SERIES 2900 SYNTHETIC CONTACT TIPS received FDA 510(k) clearance on 1989-08-10, under 510(k) number K894211.

Who is the listed applicant for SHARPLAN SERIES 2900 SYNTHETIC CONTACT TIPS?

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

What is the FDA product code for SHARPLAN SERIES 2900 SYNTHETIC CONTACT TIPS?

The FDA product code for SHARPLAN SERIES 2900 SYNTHETIC CONTACT TIPS is GEX. This falls under the Gastroenterology category.

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Other records listing Sharplan Lasers, Inc. as applicant

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Related Devices (Code: GEX)

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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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