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510(k) K012955

COAPTITE TISSUE MARKER AND COAPTITE FN TISSUE MARKER by Bioform, Inc. — Product Code NEU

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 22, 2001
Date Received
September 4, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Marker, Radiographic, Implantable
Device Class
Class II
Regulation Number
878.4300
Review Panel
SU
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)
  • K013243 — COAPTITE LARYNGEAL AUGMENTATION SYSTEM 1CC & O.5CC, MODELS 0008021-1, 0008022-1 (January 9, 2002)

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