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FDA 510(k)

POUCH, TYVEK-POLYMYLON

K-Number: K770945 · 1977-06-29

ApplicantMedical Disposables Intl., Inc.
Decision Date1977-06-29
Product CodeFPK
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

POUCH, TYVEK-POLYMYLON is the device name listed in this FDA 510(k) record. The listed applicant is Medical Disposables Intl., Inc.. It received FDA 510(k) clearance on 1977-06-29 under 510(k) number K770945. 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 POUCH, TYVEK-POLYMYLON?

POUCH, TYVEK-POLYMYLON is a medical device that received FDA 510(k) clearance on 1977-06-29. The listed applicant is Medical Disposables Intl., Inc.. The 510(k) number is K770945.

When did POUCH, TYVEK-POLYMYLON receive FDA 510(k) clearance?

POUCH, TYVEK-POLYMYLON received FDA 510(k) clearance on 1977-06-29, under 510(k) number K770945.

Who is the listed applicant for POUCH, TYVEK-POLYMYLON?

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

What is the FDA product code for POUCH, TYVEK-POLYMYLON?

The FDA product code for POUCH, TYVEK-POLYMYLON is FPK.

Related Clinical Trials

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Other records listing Medical Disposables Intl., 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.

K771231ARTEOIAL LINE KITK771230PERCUTANEOUS INTRODUCER SHEATH SETK770699NEEDLE SET, A-V FISTULAK770552CATHETER, KIDNEY DIALYSIS, HEMO-CATH IIK761078HEMO-CATH I, KIDNEY DIALYSIS CATHETER

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

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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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