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FDA 510(k)

SELECTCELLS STANDARD

K-Number: K954097 · 1995-11-21

ApplicantSelect Medical Systems, Inc.
Decision Date1995-11-21
Product CodeHHK
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

SELECTCELLS STANDARD is the device name listed in this FDA 510(k) record. The listed applicant is Select Medical Systems, Inc.. It received FDA 510(k) clearance on 1995-11-21 under 510(k) number K954097. The device is classified under product code HHK. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SELECTCELLS STANDARD?

SELECTCELLS STANDARD is a medical device that received FDA 510(k) clearance on 1995-11-21. The listed applicant is Select Medical Systems, Inc.. The 510(k) number is K954097.

When did SELECTCELLS STANDARD receive FDA 510(k) clearance?

SELECTCELLS STANDARD received FDA 510(k) clearance on 1995-11-21, under 510(k) number K954097.

Who is the listed applicant for SELECTCELLS STANDARD?

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

What is the FDA product code for SELECTCELLS STANDARD?

The FDA product code for SELECTCELLS STANDARD is HHK.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Select Medical Systems, 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.

K012935THECURVE, ITEM 507K974819SELECTCELLS(TM) MINIK954099SELECT IUIK954102SELECTMUCUSK942922SELECTA 20/60 CHEMISTRY ANALYZER

Related Devices (Code: HHK)

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.

K251882Uterine Aspiration SetGcmedica Enterprise Ltd.(Wuxi)K240434RELIEEV Suction Curette (Flexible 3.0/ Standard 3.6)Li Medical Corporation , Ltd.K201952CrossGlide ETS PlusCrossbay MedicalK192534CrossBay Endometrial Tissue Sampler (ETS)Crossbay MedicalK102847DISPOSABLE ENDOMETRIAL SUCTION CURETTEJiangsu Suyun Medical Materials Co., Ltd.K092982THE PANPAC SUCTION CURETTEPanpac Medical Corporation

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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