ISOLYER (4X4, 8PLY)— 510(k) K940755

Substantially Equivalent

Isolyer Co.

FDA 510(k) clearance K940755 for ISOLYER (4X4, 8PLY), Substantially Equivalent on 1994-05-02. Applicant: Isolyer Co.. Device class: 1.

Clearance details

Applicant: Isolyer Co.
Product code: Code NAB
Device class: Class 1
Regulation: 21 CFR 878.4014
Advisory panel: General, Plastic Surgery
Date received: 1994-02-18
Decision date: 1994-05-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Norcross, GA, US

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Data sourced from openFDA. This site is unofficial and independent of the FDA.