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510(k) K132198

ADAPTAIN, ADAPTAIN FASTWRAP, ENVELOCK, BIOWAI by Ceremed , Inc. — Product Code KHJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 12, 2013
Date Received
July 16, 2013
Clearance Type
Traditional
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 Ceremed , Inc.

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  • K122561 — ADAPTAIN FASTWRAP, ENVELOCK, GRAFTAIN (November 27, 2012)
  • K120220 — ADAPTAIN SOLUBLE IMPLANT MATERIAL (June 6, 2012)
  • K103047 — CERETENE SOLUBLE IMPLANT MATERIAL (January 5, 2011)
  • K102071 — OSTENE CT, AOC CT, OSTEOTENE, CERETENE (October 8, 2010)
  • K091636 — OSTENE CT, AOC CT, OSTEOTENE, CERETENE (June 22, 2009)
  • K082491 — OSTENE CT SOLUBLE BONE HEMOSTASIS IMPLANT MATERIAL, AOC CT, AOC, OSTENE, OSTEOTE (September 24, 2008)
  • K082245 — AOC, OSTENE, AOC IMPLANT MATERIAL, CERETENE, OSTENE LUBE, AOC-LV (September 18, 2008)

Other clearances for product code KHJ

  • K232646 — Biodesign Otologic Butterfly Graft (ENT-OTO-BFLY-0.4-0.6); Biodesign Otologic Bu (May 24, 2024)
  • K161000 — Biodesign Otologic Repair Graft (May 11, 2016)
  • K150594 — Biodesign Otologic Repair Graft (September 16, 2015)
  • K121360 — BIODESIGN ENT REPAIR GRAFT (February 27, 2013)
  • K122561 — ADAPTAIN FASTWRAP, ENVELOCK, GRAFTAIN (November 27, 2012)
  • K120220 — ADAPTAIN SOLUBLE IMPLANT MATERIAL (June 6, 2012)
  • K103047 — CERETENE SOLUBLE IMPLANT MATERIAL (January 5, 2011)
  • 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)
  • K081531 — AOC SOLUBLE IMPLANT MATERIAL (July 18, 2008)