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510(k) K013243

COAPTITE LARYNGEAL AUGMENTATION SYSTEM 1CC & O.5CC, MODELS 0008021-1, 0008022-1 by Bioform, Inc. — Product Code KHJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 9, 2002
Date Received
September 28, 2001
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 Bioform, Inc.

  • K033398 — LARYNGEAL AUGMENTATION IMPLANT (December 12, 2003)
  • K030682 — CALCIUM HYDROXYLAPATITE IMPLANT, ICC AND 0.5CC, MODELS 8038-3, 8037-3 (June 27, 2003)
  • K012955 — COAPTITE TISSUE MARKER AND COAPTITE FN TISSUE MARKER (October 22, 2001)

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  • K080022 — GEL-SPONGE ENT, ABSORBABLE GELATIN SPONGE, USP (December 9, 2008)
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