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FDA 510(k)

DISPOSABLE STORAGE CAP

K-Number: K010366 · 2001-11-28

ApplicantMolded Products, Inc.
Decision Date2001-11-28
Product CodeFJI
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

DISPOSABLE STORAGE CAP is the device name listed in this FDA 510(k) record. The listed applicant is Molded Products, Inc.. It received FDA 510(k) clearance on 2001-11-28 under 510(k) number K010366. The device is classified under product code FJI. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DISPOSABLE STORAGE CAP?

DISPOSABLE STORAGE CAP is a medical device that received FDA 510(k) clearance on 2001-11-28. The listed applicant is Molded Products, Inc.. The 510(k) number is K010366.

When did DISPOSABLE STORAGE CAP receive FDA 510(k) clearance?

DISPOSABLE STORAGE CAP received FDA 510(k) clearance on 2001-11-28, under 510(k) number K010366.

Who is the listed applicant for DISPOSABLE STORAGE CAP?

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

What is the FDA product code for DISPOSABLE STORAGE CAP?

The FDA product code for DISPOSABLE STORAGE CAP is FJI.

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Other records listing Molded Products, 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.

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Related Devices (Code: FJI)

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.

K190459Hemoflow F3 and F4 DialyzersFresenius Medical Care Renal Therapies Group, LLCK122952NIPRO PUREFLUX-L HEMODIALYZERNipro Medical CorporationK043342POLYFLUX FAMILY HEMODIALYZER/FILTER LABELED FOR SINGLE AND MULTIPLE USE, MODELS 14L, 17L, 21L, 140H, 170H, 210H,6LR, 8LRGambro Renal ProductsK011148ULTRACONCENTRATOR SYSTEMInterpore Cross Intl.K002761FRESNIUS HEMOFLOW F7NR, F50NR, F70NR HEMODIALYZERSFresenius Medical Care North AmericaK991908IDEMSA HEMOPHAN HOLLOW FIBER DIALYZERSIdemsa

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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