PROMEDICAL SURGICAL DRAPES, PROMEDICAL SURGICAL MAYO STAND COVER, BAND BAGS— 510(k) K080629

Name: FDA 510(k) clearance K080629
Creator: U.S. Food and Drug Administration
Published: 2008-10-20

Substantially Equivalent

Promedical Products Co., Ltd.

FDA 510(k) clearance K080629 for PROMEDICAL SURGICAL DRAPES, PROMEDICAL SURGICAL MAYO STAND COVER, BAND BAGS, Substantially Equivalent on 2008-10-20. Applicant: Promedical Products Co., Ltd.. Device class: 2.

Clearance details

Applicant: Promedical Products Co., Ltd.
Product code: Code KKX
Device class: Class 2
Regulation: 21 CFR 878.4370
Advisory panel: General, Plastic Surgery
Date received: 2008-03-05
Decision date: 2008-10-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Changzhou, Jiangsu, CN

Download summary PDF View on FDA.gov ↗

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