FDA 510(k)

PACKAGING AND MANUFACTURING METHODS CHANGE/KNEE COMPONENTS

K-Number: K936292 · 1995-08-18

Decision Date1995-08-18

Product CodeLPH

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

PACKAGING AND MANUFACTURING METHODS CHANGE/KNEE COMPONENTS is the device name listed in this FDA 510(k) record. The listed applicant is Howmedica Corp.. It received FDA 510(k) clearance on 1995-08-18 under 510(k) number K936292. The device is classified under product code LPH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PACKAGING AND MANUFACTURING METHODS CHANGE/KNEE COMPONENTS?

PACKAGING AND MANUFACTURING METHODS CHANGE/KNEE COMPONENTS is a medical device that received FDA 510(k) clearance on 1995-08-18. The listed applicant is Howmedica Corp.. The 510(k) number is K936292.

When did PACKAGING AND MANUFACTURING METHODS CHANGE/KNEE COMPONENTS receive FDA 510(k) clearance?

PACKAGING AND MANUFACTURING METHODS CHANGE/KNEE COMPONENTS received FDA 510(k) clearance on 1995-08-18, under 510(k) number K936292.

Who is the listed applicant for PACKAGING AND MANUFACTURING METHODS CHANGE/KNEE COMPONENTS?

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

What is the FDA product code for PACKAGING AND MANUFACTURING METHODS CHANGE/KNEE COMPONENTS?

The FDA product code for PACKAGING AND MANUFACTURING METHODS CHANGE/KNEE COMPONENTS is LPH.

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Other records listing Howmedica Corp. as applicant

K983528MICRO DYNAMIC MESH K983404TYPE 3 FEMORAL COMPONENTS K980926DURATION II ACETABULAR COMPONENTS-ETHYLENE OXIDE STERILIZATION K980925DURATION II TIBIAL INSERTS-ETHYLENE OXIDE STERILIZATION K980626DURATION II ACETABULAR COMPONENTS-GAS PLASMA STERILIZATION K980632DURATION II TIBIAL INSERTS - GAS PLASMA STERILIZATION

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.