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FDA 510(k)

CYCLOTECH CYCLOSPORINE ORAL SOLUTIONS DISPENSER

K-Number: K980109 · 1998-08-18

ApplicantSangstat Medical Corp.
Decision Date1998-08-18
Product CodeKYX
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

CYCLOTECH CYCLOSPORINE ORAL SOLUTIONS DISPENSER is the device name listed in this FDA 510(k) record. The listed applicant is Sangstat Medical Corp.. It received FDA 510(k) clearance on 1998-08-18 under 510(k) number K980109. The device is classified under product code KYX. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CYCLOTECH CYCLOSPORINE ORAL SOLUTIONS DISPENSER?

CYCLOTECH CYCLOSPORINE ORAL SOLUTIONS DISPENSER is a medical device that received FDA 510(k) clearance on 1998-08-18. The listed applicant is Sangstat Medical Corp.. The 510(k) number is K980109.

When did CYCLOTECH CYCLOSPORINE ORAL SOLUTIONS DISPENSER receive FDA 510(k) clearance?

CYCLOTECH CYCLOSPORINE ORAL SOLUTIONS DISPENSER received FDA 510(k) clearance on 1998-08-18, under 510(k) number K980109.

Who is the listed applicant for CYCLOTECH CYCLOSPORINE ORAL SOLUTIONS DISPENSER?

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

What is the FDA product code for CYCLOTECH CYCLOSPORINE ORAL SOLUTIONS DISPENSER?

The FDA product code for CYCLOTECH CYCLOSPORINE ORAL SOLUTIONS DISPENSER is KYX.

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Other records listing Sangstat Medical Corp. as applicant

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Related Devices (Code: KYX)

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.

K954181CANYONS BI-DIRECTIONAL CHECK VALVECanyon Medical ProductsK830571BOTTLE ADAPTERBurron Medical Products, Inc.K801008MULTI-AD FLUID DISPENSING PUMP MP-3000Burron Medical Products, Inc.K800362FLUID DISPENSING SYSTEMPharmaseal LaboratoriesK800437SYRINGE TIP CONNECTORBurron Medical Products, Inc.K792227MULTI-AD FLUID DISPENSING SYSTEMNational Patent Development 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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