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FDA 510(k)

STRATASYS FDM MEDMODELER SYSTEM

K-Number: K971290 · 1997-06-20

ApplicantPaladin Medical, Inc.
Decision Date1997-06-20
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

STRATASYS FDM MEDMODELER SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Paladin Medical, Inc.. It received FDA 510(k) clearance on 1997-06-20 under 510(k) number K971290. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STRATASYS FDM MEDMODELER SYSTEM?

STRATASYS FDM MEDMODELER SYSTEM is a medical device that received FDA 510(k) clearance on 1997-06-20. The listed applicant is Paladin Medical, Inc.. The 510(k) number is K971290.

When did STRATASYS FDM MEDMODELER SYSTEM receive FDA 510(k) clearance?

STRATASYS FDM MEDMODELER SYSTEM received FDA 510(k) clearance on 1997-06-20, under 510(k) number K971290.

Who is the listed applicant for STRATASYS FDM MEDMODELER SYSTEM?

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

What is the FDA product code for STRATASYS FDM MEDMODELER SYSTEM?

The FDA product code for STRATASYS FDM MEDMODELER SYSTEM is LLZ.

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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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