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510(k) K123394

CORELEADER HYDRO-HEALER HYDROCOLLOID WOUND DRESSING by Coreleader Biotech Co., Ltd. — Product Code FRO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 6, 2013
Date Received
November 2, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dressing, Wound, Drug
Device Class
Class U
Regulation Number
Review Panel
SU
Submission Type

Other clearances by Coreleader Biotech Co., Ltd.

  • K151204 — HEMO-Bandage (July 31, 2015)
  • K141382 — BIOS KING BIOCELLULOSE FILM (February 10, 2015)
  • K111578 — CORELEADER COLLA-ALGI FIBER MODEL CAW (September 23, 2011)
  • K111733 — CORELEADER SCAR-DIMMER (September 22, 2011)
  • K102944 — CORELEADER HEMO-PAD MODEL CPII 02030 (September 7, 2011)
  • K102942 — CORELEADER ALGIPLASTER MODEL AP 050501 (June 22, 2011)
  • K102946 — CORELEADER COLLA-PAD MODEL CS 03030 (May 20, 2011)
  • K102943 — CORELEADER ALGI-FIBER WOUND DRESSING MODEL ADW 05050 (April 12, 2011)

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