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FDA 510(k)

SHARPLAN MODELS 719-O COLPOSLAD CO2 SU MICROMANI.

K-Number: K881952 · 1988-06-03

ApplicantSharplan Lasers, Inc.
Decision Date1988-06-03
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SHARPLAN MODELS 719-O COLPOSLAD CO2 SU MICROMANI. 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 1988-06-03 under 510(k) number K881952. 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 MODELS 719-O COLPOSLAD CO2 SU MICROMANI.?

SHARPLAN MODELS 719-O COLPOSLAD CO2 SU MICROMANI. is a medical device that received FDA 510(k) clearance on 1988-06-03. The listed applicant is Sharplan Lasers, Inc.. The 510(k) number is K881952.

When did SHARPLAN MODELS 719-O COLPOSLAD CO2 SU MICROMANI. receive FDA 510(k) clearance?

SHARPLAN MODELS 719-O COLPOSLAD CO2 SU MICROMANI. received FDA 510(k) clearance on 1988-06-03, under 510(k) number K881952.

Who is the listed applicant for SHARPLAN MODELS 719-O COLPOSLAD CO2 SU MICROMANI.?

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 MODELS 719-O COLPOSLAD CO2 SU MICROMANI.?

The FDA product code for SHARPLAN MODELS 719-O COLPOSLAD CO2 SU MICROMANI. 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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