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FDA 510(k)

SINOVENT MAXILLARY SINUS DRAINAGE SYSTEM

K-Number: K896630 · 1990-06-06

ApplicantAtos Medical AB
Decision Date1990-06-06
Product CodeKAM
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SINOVENT MAXILLARY SINUS DRAINAGE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Atos Medical AB. It received FDA 510(k) clearance on 1990-06-06 under 510(k) number K896630. The device is classified under product code KAM. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SINOVENT MAXILLARY SINUS DRAINAGE SYSTEM?

SINOVENT MAXILLARY SINUS DRAINAGE SYSTEM is a medical device that received FDA 510(k) clearance on 1990-06-06. The listed applicant is Atos Medical AB. The 510(k) number is K896630.

When did SINOVENT MAXILLARY SINUS DRAINAGE SYSTEM receive FDA 510(k) clearance?

SINOVENT MAXILLARY SINUS DRAINAGE SYSTEM received FDA 510(k) clearance on 1990-06-06, under 510(k) number K896630.

Who is the listed applicant for SINOVENT MAXILLARY SINUS DRAINAGE SYSTEM?

The FDA 510(k) record lists Atos Medical AB as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SINOVENT MAXILLARY SINUS DRAINAGE SYSTEM?

The FDA product code for SINOVENT MAXILLARY SINUS DRAINAGE SYSTEM is KAM.

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Other records listing Atos Medical AB 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.

K151404ProTrach DualcareK131947PROVOX VEGA PUNCTURE SETK092593PROVOX ACTIVALVE (SIZE 4.5MM, 6MM, 8MM, 10MM, 12.5MM)K090455PROVOX VEGA, MODEL 8130-8135K072582PROVOX MICRON HMEK043138PROVOX NID VOICE REHABILITATION SYSTEM, MODEL REF 7101 TO 7134

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Related Devices (Code: KAM)

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.

K110687RELIEVA STRATUS PRO MICROFLOW SPACER (FRONTAL)Acclarent, Inc.K093594MODIFICATION TO RELIEVA STRATUS MICROFLOW SPACERAcclarent, Inc.K083574RELIEVA STRATUS MICROFLOW SPACERAcclarent, Inc.K072891SINUS SPACERAcclarent, Inc.K073041RELIEVA AND RELIEVA ACELLA SINUS BALLOON CATHETERAcclarent, Inc.K071845RELIEVA LUMA SINUS ILLUMINATION SYSTEM, MODEL SIS-100AAcclarent, 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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