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FDA 510(k)

PLASTELAST AND/OR ELASTOPLASTE

K-Number: K854006 · 1985-11-25

ApplicantCp Medical
Decision Date1985-11-25
Product CodeKGX
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

PLASTELAST AND/OR ELASTOPLASTE is the device name listed in this FDA 510(k) record. The listed applicant is Cp Medical. It received FDA 510(k) clearance on 1985-11-25 under 510(k) number K854006. The device is classified under product code KGX. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PLASTELAST AND/OR ELASTOPLASTE?

PLASTELAST AND/OR ELASTOPLASTE is a medical device that received FDA 510(k) clearance on 1985-11-25. The listed applicant is Cp Medical. The 510(k) number is K854006.

When did PLASTELAST AND/OR ELASTOPLASTE receive FDA 510(k) clearance?

PLASTELAST AND/OR ELASTOPLASTE received FDA 510(k) clearance on 1985-11-25, under 510(k) number K854006.

Who is the listed applicant for PLASTELAST AND/OR ELASTOPLASTE?

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

What is the FDA product code for PLASTELAST AND/OR ELASTOPLASTE?

The FDA product code for PLASTELAST AND/OR ELASTOPLASTE is KGX.

Related Clinical Trials

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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Other records listing Cp Medical 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.

K094028CP-FIBER (ORTHOFIBER)K072229MONOSWIFTK071550PRE-WAXED NEEDLES WITH GOLD FIDUCIARY MARKERSK060987OSCERA7 SYNTHETIC ABSORBABLE BONE WAX, MODEL OS31K041894ORTHOFIBERK034062CP SLEEVE AND RIVER SLEEVE

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Related Devices (Code: KGX)

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.

K001240SERAGARD INJECTION PATCHPlatinum Services, Inc.K983368CARE BAND ANTIBACTERIAL BANDAGESAso Corp.K972914SYVEK PATCHMarine Polymer Technologies, Inc.K943314ADHESIVE BANDAGES WITH OTC DRUGJohnson & Johnson Consumer Products, Inc.K952606TARGETT PATCHCutting Edge Technologies, Inc.K954007PARALLELJohnson & Johnson Consumer Products, 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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