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510(k) K771011

ARTICULATING PAPER by Parker Laboratories, Inc. — Product Code EFH

K771011 is an FDA 510(k) premarket notification submitted by Parker Laboratories, Inc. for the device "ARTICULATING PAPER". The FDA issued a decision of Substantially Equivalent on June 20, 1977. The device falls under product code EFH (Paper, Articulation), a Class I device regulated under 21 CFR 872.6140. Parker Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 20, 1977
Date Received
June 6, 1977
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 by Parker Laboratories, Inc.

  • K233965 — UltraDrape UGPIV Barrier and Securement (34-15) (August 15, 2024)
  • K953673 — ECLIPSE PROBE COVER (March 14, 1996)
  • K921695 — ULTRA COVER ULTRASOUND TRANSDUCER PROBE COVERS (February 23, 1995)
  • K864556 — AQUALUBE(TM) (December 1, 1986)
  • K861239 — ACRYLIC SOLDER (April 17, 1986)
  • K855167 — DYNA SYSTEM (March 4, 1986)
  • K851895 — POLYGEL ULTRASOUND GEL (September 27, 1985)
  • K852956 — CONTACT CONDUCTIVE ADHESIVE GEL COMPOSITION (August 9, 1985)
  • K841400 — NEURO PULSE (June 15, 1984)
  • K840548 — RESIL (April 17, 1984)

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)
  • K870032 — REVISED T-SCAN SYSTEM (February 2, 1987)
  • K832647 — ARTICULATING PAPER (February 21, 1984)
  • K833132 — MUCOSAL ADJUSTMENT PASTE LIQUID SPRAY (February 10, 1984)
  • K810498 — CENTRIC (BITE) REGISTRATION PASTE (March 17, 1981)
  • K770492 — CRACK DETECTOR, DEN-MAT (March 21, 1977)

FDA data resources