FDA 510(k) clearance · back to tracker

NAVARRE LOCKING PIGTAIL UNIVERSAL DRAINAGE CATHETER

Navarre Biomedical , Ltd. cleared K951907 on 1995-05-15, decision: substantially equivalent

K-number

K951907

Sponsor

Navarre Biomedical , Ltd.

Device

NAVARRE LOCKING PIGTAIL UNIVERSAL DRAINAGE CATHETER

Class

Class I

Decision

Substantially Equivalent

Decision date

1995-05-15

Product code

GBX

Advisory committee

General, Plastic Surgery

Medical specialty

General, Plastic Surgery

Regulation number

878.4200

Official FDA record

Open K951907on accessdata.fda.gov →

FDA's authoritative 510(k) summary page. Includes the decision letter, predicate references, and downloadable substantial-equivalence determination.

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Source

Public 510(k) database, U.S. Food and Drug Administration, accessed via openFDA. Page refreshed weekly.