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FDA 510(k)

SILCLEAR TUBING (MODIFICATION)

K-Number: K953864 · 1995-11-06

ApplicantDegania Silicone , Ltd.
Decision Date1995-11-06
Product CodeFPK
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SILCLEAR TUBING (MODIFICATION) is the device name listed in this FDA 510(k) record. The listed applicant is Degania Silicone , Ltd.. It received FDA 510(k) clearance on 1995-11-06 under 510(k) number K953864. 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 SILCLEAR TUBING (MODIFICATION)?

SILCLEAR TUBING (MODIFICATION) is a medical device that received FDA 510(k) clearance on 1995-11-06. The listed applicant is Degania Silicone , Ltd.. The 510(k) number is K953864.

When did SILCLEAR TUBING (MODIFICATION) receive FDA 510(k) clearance?

SILCLEAR TUBING (MODIFICATION) received FDA 510(k) clearance on 1995-11-06, under 510(k) number K953864.

Who is the listed applicant for SILCLEAR TUBING (MODIFICATION)?

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

What is the FDA product code for SILCLEAR TUBING (MODIFICATION)?

The FDA product code for SILCLEAR TUBING (MODIFICATION) is FPK.

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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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