TOP DRAPE STERILE, TOP DRAPE-NON STERILE, BOTTOM DRAPE- STERILE, BOTTOM DRAPE— 510(k) K112136

Name: FDA 510(k) clearance K112136
Creator: U.S. Food and Drug Administration
Published: 2011-09-29

Substantially Equivalent

Kunshan Jiehong Nonwoven Product Co., Ltd.

FDA 510(k) clearance K112136 for TOP DRAPE STERILE, TOP DRAPE-NON STERILE, BOTTOM DRAPE- STERILE, BOTTOM DRAPE, Substantially Equivalent on 2011-09-29. Applicant: Kunshan Jiehong Nonwoven Product Co., Ltd.. Device class: 2.

Clearance details

Applicant: Kunshan Jiehong Nonwoven Product Co., Ltd.
Product code: Code KKX
Device class: Class 2
Regulation: 21 CFR 878.4370
Advisory panel: General, Plastic Surgery
Date received: 2011-07-26
Decision date: 2011-09-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

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