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FDA 510(k)

SPACELINE FEEL 21

K-Number: K953865 · 1996-03-20

ApplicantJ. Morita USA, Inc.
Decision Date1996-03-20
Product CodeEFA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SPACELINE FEEL 21 is the device name listed in this FDA 510(k) record. The listed applicant is J. Morita USA, Inc.. It received FDA 510(k) clearance on 1996-03-20 under 510(k) number K953865. The device is classified under product code EFA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPACELINE FEEL 21?

SPACELINE FEEL 21 is a medical device that received FDA 510(k) clearance on 1996-03-20. The listed applicant is J. Morita USA, Inc.. The 510(k) number is K953865.

When did SPACELINE FEEL 21 receive FDA 510(k) clearance?

SPACELINE FEEL 21 received FDA 510(k) clearance on 1996-03-20, under 510(k) number K953865.

Who is the listed applicant for SPACELINE FEEL 21?

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

What is the FDA product code for SPACELINE FEEL 21?

The FDA product code for SPACELINE FEEL 21 is EFA.

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Related Devices (Code: EFA)

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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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