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FDA 510(k)

DANMAR PRODUCTS CRANIAL ADJUSTIVE PROSTHESIS

K-Number: K013452 · 2003-10-31

ApplicantDanmar Products, Inc.
Decision Date2003-10-31
Product CodeMVA
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

DANMAR PRODUCTS CRANIAL ADJUSTIVE PROSTHESIS is the device name listed in this FDA 510(k) record. The listed applicant is Danmar Products, Inc.. It received FDA 510(k) clearance on 2003-10-31 under 510(k) number K013452. The device is classified under product code MVA. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DANMAR PRODUCTS CRANIAL ADJUSTIVE PROSTHESIS?

DANMAR PRODUCTS CRANIAL ADJUSTIVE PROSTHESIS is a medical device that received FDA 510(k) clearance on 2003-10-31. The listed applicant is Danmar Products, Inc.. The 510(k) number is K013452.

When did DANMAR PRODUCTS CRANIAL ADJUSTIVE PROSTHESIS receive FDA 510(k) clearance?

DANMAR PRODUCTS CRANIAL ADJUSTIVE PROSTHESIS received FDA 510(k) clearance on 2003-10-31, under 510(k) number K013452.

Who is the listed applicant for DANMAR PRODUCTS CRANIAL ADJUSTIVE PROSTHESIS?

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

What is the FDA product code for DANMAR PRODUCTS CRANIAL ADJUSTIVE PROSTHESIS?

The FDA product code for DANMAR PRODUCTS CRANIAL ADJUSTIVE PROSTHESIS is MVA.

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Other records listing Danmar Products, Inc. as applicant

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Related Devices (Code: MVA)

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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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