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FDA 510(k)

PACE SAVER, LITTLE JUNIOR (MODIFICATION)(MOTORIZED THREE-WHEELED VEHICLE)

K-Number: K965123 · 1997-07-17

ApplicantBurke, Inc.
Decision Date1997-07-17
Product CodeINI
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

PACE SAVER, LITTLE JUNIOR (MODIFICATION)(MOTORIZED THREE-WHEELED VEHICLE) is the device name listed in this FDA 510(k) record. The listed applicant is Burke, Inc.. It received FDA 510(k) clearance on 1997-07-17 under 510(k) number K965123. The device is classified under product code INI. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PACE SAVER, LITTLE JUNIOR (MODIFICATION)(MOTORIZED THREE-WHEELED VEHICLE)?

PACE SAVER, LITTLE JUNIOR (MODIFICATION)(MOTORIZED THREE-WHEELED VEHICLE) is a medical device that received FDA 510(k) clearance on 1997-07-17. The listed applicant is Burke, Inc.. The 510(k) number is K965123.

When did PACE SAVER, LITTLE JUNIOR (MODIFICATION)(MOTORIZED THREE-WHEELED VEHICLE) receive FDA 510(k) clearance?

PACE SAVER, LITTLE JUNIOR (MODIFICATION)(MOTORIZED THREE-WHEELED VEHICLE) received FDA 510(k) clearance on 1997-07-17, under 510(k) number K965123.

Who is the listed applicant for PACE SAVER, LITTLE JUNIOR (MODIFICATION)(MOTORIZED THREE-WHEELED VEHICLE)?

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

What is the FDA product code for PACE SAVER, LITTLE JUNIOR (MODIFICATION)(MOTORIZED THREE-WHEELED VEHICLE)?

The FDA product code for PACE SAVER, LITTLE JUNIOR (MODIFICATION)(MOTORIZED THREE-WHEELED VEHICLE) is INI.

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Other records listing Burke, Inc. as applicant

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Related Devices (Code: INI)

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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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