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FDA 510(k)

C-FLEX MEDICAL GRADE TUBING

K-Number: K833076 · 1983-11-21

ApplicantConcept, Inc.
Decision Date1983-11-21
Product CodeFPK
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

C-FLEX MEDICAL GRADE TUBING is the device name listed in this FDA 510(k) record. The listed applicant is Concept, Inc.. It received FDA 510(k) clearance on 1983-11-21 under 510(k) number K833076. The device is classified under product code FPK. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the C-FLEX MEDICAL GRADE TUBING?

C-FLEX MEDICAL GRADE TUBING is a medical device that received FDA 510(k) clearance on 1983-11-21. The listed applicant is Concept, Inc.. The 510(k) number is K833076.

When did C-FLEX MEDICAL GRADE TUBING receive FDA 510(k) clearance?

C-FLEX MEDICAL GRADE TUBING received FDA 510(k) clearance on 1983-11-21, under 510(k) number K833076.

Who is the listed applicant for C-FLEX MEDICAL GRADE TUBING?

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

What is the FDA product code for C-FLEX MEDICAL GRADE TUBING?

The FDA product code for C-FLEX MEDICAL GRADE TUBING is FPK.

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Other records listing Concept, 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.

K912640CONCEPT ENDOSTEAL FIXATION DEVICEK912957CONCEPT MICROMILLK896648CONCEPT UNICOMPARTMENTAL KNEE SYSTEMK894929STAPLE FIXATION SYSTEMK892376INTRAVISION(TM) ARTHROSCOPE SYSTEM (ADD'L APPLI.)K891109PANDA(R) NEEDLE CATHETER JEJUNOSTOMY TUBE

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Related Devices (Code: FPK)

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.

K131517MEDRAD TWIST & GO HIGH PRESSURE CONNECTOR TUBINGMedrad, Inc. / Bayer Medical Care, Inc.K063114DISPOSABLE TRANSFER SETS WITH AND WITHOUT SWABBABLE VALVES AND/OR CHECK VALVESCoeur, Inc.K063239LIFESHIELD LATEX-FREE GRAVITECH FLOW CONTROLLER I.V. SETS, MODELS 17528, 17527, 17525 & 17526Hospira, Inc.K052431MEDTRONIC MINIMED LEAPFROG II INFUSION SET, MODELS MMT-801S1, MMT-801L1, MMT-801S2, MMT-801L2, MMT-803S1Medtronic MinimedK041178EMPOWER TRANSFER SET, (CAT. NO. 7725)E-Z-Em, Inc.K031808MEDRAD SWABBABLE VALVE TRANSFER SETMedrad, 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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