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510(k) K112136

TOP DRAPE STERILE, TOP DRAPE-NON STERILE, BOTTOM DRAPE- STERILE, BOTTOM DRAPE by Kunshan Jiehong Nonwoven Product Co., Ltd. — Product Code KKX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 29, 2011
Date Received
July 26, 2011
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Drape, Surgical
Device Class
Class II
Regulation Number
878.4370
Review Panel
HO
Submission Type

Other clearances by Kunshan Jiehong Nonwoven Product Co., Ltd.

  • K111067 — JIE+HONG MEDICAL SURGICAL GOWNS - STERILE, JIE+HONG MEDICAL SURGICAL GOWNS - NON (August 2, 2011)

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