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FDA 510(k)

THECURVE, ITEM 507

K-Number: K012935 · 2001-10-11

ApplicantSelect Medical Systems, Inc.
Decision Date2001-10-11
Product CodeMFD
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

THECURVE, ITEM 507 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 2001-10-11 under 510(k) number K012935. The device is classified under product code MFD. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THECURVE, ITEM 507?

THECURVE, ITEM 507 is a medical device that received FDA 510(k) clearance on 2001-10-11. The listed applicant is Select Medical Systems, Inc.. The 510(k) number is K012935.

When did THECURVE, ITEM 507 receive FDA 510(k) clearance?

THECURVE, ITEM 507 received FDA 510(k) clearance on 2001-10-11, under 510(k) number K012935.

Who is the listed applicant for THECURVE, ITEM 507?

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 THECURVE, ITEM 507?

The FDA product code for THECURVE, ITEM 507 is MFD.

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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.

K974819SELECTCELLS(TM) MINIK954099SELECT IUIK954102SELECTMUCUSK954097SELECTCELLS STANDARDK942922SELECTA 20/60 CHEMISTRY ANALYZER

Related Devices (Code: MFD)

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.

K021438INSEMINATION CATHETER, MODEL 320301Labotect Labor-Technik GottingenK984306`THE INSEMINATOR' (PROPOSED)Wallach Surgical Devices, Inc.K982630MEDWORKS VISUALIZATION INSEMINATION CATHETERMedworks Corp.K982628MEDWORKS INSEMINATION CATHETERMedworks Corp.K980061EMBRYON INTRAUTERINE INSEMINATION CATHETER, EMRYON SOFT INTRAUTERINE INSEMINATION CATHETER, STYLET FOR EMBRYON INTRAUTERRocket Medical PlcK972823MINI-EMBRYON INTRA UTERINE INSEMINATION CATHETERA & A Medical, Inc.

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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