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FDA 510(k)

PROSTYLE COMPACT

K-Number: K961420 · 1996-09-10

ApplicantPlanmeca Oy
Decision Date1996-09-10
Product CodeEIA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PROSTYLE COMPACT is the device name listed in this FDA 510(k) record. The listed applicant is Planmeca Oy. It received FDA 510(k) clearance on 1996-09-10 under 510(k) number K961420. The device is classified under product code EIA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PROSTYLE COMPACT?

PROSTYLE COMPACT is a medical device that received FDA 510(k) clearance on 1996-09-10. The listed applicant is Planmeca Oy. The 510(k) number is K961420.

When did PROSTYLE COMPACT receive FDA 510(k) clearance?

PROSTYLE COMPACT received FDA 510(k) clearance on 1996-09-10, under 510(k) number K961420.

Who is the listed applicant for PROSTYLE COMPACT?

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

What is the FDA product code for PROSTYLE COMPACT?

The FDA product code for PROSTYLE COMPACT is EIA.

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Other records listing Planmeca Oy as applicant

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Related Devices (Code: EIA)

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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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