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510(k) K870032

REVISED T-SCAN SYSTEM by Sentek, Inc. — Product Code EFH

K870032 is an FDA 510(k) premarket notification submitted by Sentek, Inc. for the device "REVISED T-SCAN SYSTEM". The FDA issued a decision of Substantially Equivalent on February 2, 1987. The device falls under product code EFH (Paper, Articulation), a Class I device regulated under 21 CFR 872.6140.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 2, 1987
Date Received
January 5, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Paper, Articulation
Device Class
Class I
Regulation Number
872.6140
Review Panel
DE
Submission Type

Other clearances for product code EFH

  • K965026 — PFINGST PRESSURE PASTE (February 10, 1997)
  • K912632 — OCCLUDE (January 17, 1992)
  • K911259 — HYDENT (June 6, 1991)
  • K864572 — FIXTECTOR (February 12, 1987)
  • K832647 — ARTICULATING PAPER (February 21, 1984)
  • K833132 — MUCOSAL ADJUSTMENT PASTE LIQUID SPRAY (February 10, 1984)
  • K810498 — CENTRIC (BITE) REGISTRATION PASTE (March 17, 1981)
  • K771011 — ARTICULATING PAPER (June 20, 1977)
  • K770492 — CRACK DETECTOR, DEN-MAT (March 21, 1977)

FDA data resources