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510(k) K111067

JIE+HONG MEDICAL SURGICAL GOWNS - STERILE, JIE+HONG MEDICAL SURGICAL GOWNS - NON STERILE by Kunshan Jiehong Nonwoven Product Co., Ltd. — Product Code FYA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 2, 2011
Date Received
April 18, 2011
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Gown, Surgical
Device Class
Class II
Regulation Number
878.4040
Review Panel
HO
Submission Type

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

  • K112136 — TOP DRAPE STERILE, TOP DRAPE-NON STERILE, BOTTOM DRAPE- STERILE, BOTTOM DRAPE (September 29, 2011)

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