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FDA 510(k)

LUNDEEN SUBTALAR PEG IMPLANT

K-Number: K922292 · 1992-10-23

ApplicantSgarlato Laboratories, Inc.
Decision Date1992-10-23
Product CodeMJW
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

LUNDEEN SUBTALAR PEG IMPLANT is the device name listed in this FDA 510(k) record. The listed applicant is Sgarlato Laboratories, Inc.. It received FDA 510(k) clearance on 1992-10-23 under 510(k) number K922292. The device is classified under product code MJW. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LUNDEEN SUBTALAR PEG IMPLANT?

LUNDEEN SUBTALAR PEG IMPLANT is a medical device that received FDA 510(k) clearance on 1992-10-23. The listed applicant is Sgarlato Laboratories, Inc.. The 510(k) number is K922292.

When did LUNDEEN SUBTALAR PEG IMPLANT receive FDA 510(k) clearance?

LUNDEEN SUBTALAR PEG IMPLANT received FDA 510(k) clearance on 1992-10-23, under 510(k) number K922292.

Who is the listed applicant for LUNDEEN SUBTALAR PEG IMPLANT?

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

What is the FDA product code for LUNDEEN SUBTALAR PEG IMPLANT?

The FDA product code for LUNDEEN SUBTALAR PEG IMPLANT is MJW.

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Other records listing Sgarlato Laboratories, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K043204SGARLATO LABS PAINFREE PUMP AND PAIN CONTROL INFUSION PUMPK990101PAIN CONTROL INFUSION PUMPK982931THREADED FIXATION PINK926262FIRST MPJ CONTINUOUS PASSIVE MOTION DEVICEK926237O'BRIEN GONIOMETERK905795SGARLATO FLEXIBLE HINGE TOE IMPLANT

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Related Devices (Code: MJW)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K033046SUBTALAR PEG IMPLANTNexa Orthopedics, Inc.

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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