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510(k) K921571

1ST IMPRESSION by Wykle Research, Inc. — Product Code ELW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 10, 1993
Date Received
April 2, 1992
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

Other clearances by Wykle Research, Inc.

  • K952670 — CUPRALLOY (August 25, 1995)
  • K910632 — ACCU-MIX AMALGAMATOR (March 15, 1991)

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