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510(k) K102946

CORELEADER COLLA-PAD MODEL CS 03030 by Coreleader Biotech Co., Ltd. — Product Code KGN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 20, 2011
Date Received
October 4, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Wound Dressing With Animal-Derived Material(S)
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)
  • K123394 — CORELEADER HYDRO-HEALER HYDROCOLLOID WOUND DRESSING (June 6, 2013)
  • 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)
  • K102943 — CORELEADER ALGI-FIBER WOUND DRESSING MODEL ADW 05050 (April 12, 2011)

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