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510(k) K060878

GELITA-SPON ABSORBABLE GELATIN SPONGE, USP by Curamedical, BV — Product Code KHJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 13, 2006
Date Received
March 31, 2006
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material)
Device Class
Class II
Regulation Number
874.3620
Review Panel
EN
Submission Type

Other clearances by Curamedical, BV

  • K051911 — GELITA-SPON (December 6, 2005)

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  • K080022 — GEL-SPONGE ENT, ABSORBABLE GELATIN SPONGE, USP (December 9, 2008)
  • K082245 — AOC, OSTENE, AOC IMPLANT MATERIAL, CERETENE, OSTENE LUBE, AOC-LV (September 18, 2008)