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510(k) K955465

DEGUPRINT by Degussa Corp. — Product Code ELW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 28, 1995
Date Received
November 30, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Material, Impression
Device Class
Class II
Regulation Number
872.3660
Review Panel
DE
Submission Type

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  • K960104 — BIOCCLUS 4 (February 6, 1996)
  • K955118 — DEGUBOND X-LITE PLUS (December 11, 1995)
  • K955027 — DEGUBOND X-LITE (December 1, 1995)
  • K953344 — DEGUBOND ULTRA (August 25, 1995)
  • K951789 — PALLIAG NF IV (June 14, 1995)
  • K951790 — PONTALLOR 3 (June 12, 1995)

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