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510(k) K851895

POLYGEL ULTRASOUND GEL by Parker Laboratories, Inc. — Product Code IYO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 27, 1985
Date Received
April 30, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Imaging, Pulsed Echo, Ultrasonic
Device Class
Class II
Regulation Number
892.1560
Review Panel
RA
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)
  • K852956 — CONTACT CONDUCTIVE ADHESIVE GEL COMPOSITION (August 9, 1985)
  • K841400 — NEURO PULSE (June 15, 1984)
  • K840548 — RESIL (April 17, 1984)
  • K831039 — COMPLUS VARIOUS FORMS (May 27, 1983)

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