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FDA 510(k)

STERILE/DISPOSABLE HSG TRAY

K-Number: K810291 · 1981-03-18

ApplicantUnimar, Inc.
Decision Date1981-03-18
Product CodeEYY
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

STERILE/DISPOSABLE HSG TRAY is the device name listed in this FDA 510(k) record. The listed applicant is Unimar, Inc.. It received FDA 510(k) clearance on 1981-03-18 under 510(k) number K810291. The device is classified under product code EYY. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STERILE/DISPOSABLE HSG TRAY?

STERILE/DISPOSABLE HSG TRAY is a medical device that received FDA 510(k) clearance on 1981-03-18. The listed applicant is Unimar, Inc.. The 510(k) number is K810291.

When did STERILE/DISPOSABLE HSG TRAY receive FDA 510(k) clearance?

STERILE/DISPOSABLE HSG TRAY received FDA 510(k) clearance on 1981-03-18, under 510(k) number K810291.

Who is the listed applicant for STERILE/DISPOSABLE HSG TRAY?

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

What is the FDA product code for STERILE/DISPOSABLE HSG TRAY?

The FDA product code for STERILE/DISPOSABLE HSG TRAY is EYY.

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Other records listing Unimar, 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.

K932432KRONNER REINFORCING STYLETTEK920803HSG TRAYK910317UNI-SEM(TM)K904473KRONNER MANIPUJECTORK895659HUI MINI-FLEXK895403ASPIRETTE ENDOCERVICAL ASPIRATOR

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Related Devices (Code: EYY)

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.

K851675THE PERCUTANEOUS NEPHROSTOLITHOTOMY DRAPELingeman Medical Products, 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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