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510(k) K855167

DYNA SYSTEM by Parker Laboratories, Inc. — Product Code EGG

K855167 is an FDA 510(k) premarket notification submitted by Parker Laboratories, Inc. for the device "DYNA SYSTEM". The FDA issued a decision of Substantially Equivalent on March 4, 1986. The device falls under product code EGG (Attachment, Precision, All), a Class I device regulated under 21 CFR 872.3165. Parker Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 4, 1986
Date Received
December 26, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Attachment, Precision, All
Device Class
Class I
Regulation Number
872.3165
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)
  • 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)
  • K831039 — COMPLUS VARIOUS FORMS (May 27, 1983)

Other clearances for product code EGG

  • K990979 — STECO-TITANMAGNETICS (September 3, 1999)
  • K950259 — COUPLING DEVICE FOR DENTAL PROSTHESIS (December 6, 1996)
  • K925700 — ZEST ANCHOR ADVANCED GENERATION (April 7, 1994)
  • K915299 — COGAN CORP KITS OF DENTAL HAND INSTRUMENTS (January 31, 1992)
  • K912435 — DENTAL CONNECTOR PRECISION ATTACHMENT (August 28, 1991)
  • K912567 — CONICAST, INTRACAST, OMECAST (July 2, 1991)
  • K901928 — INTERPORE IMZ(CASTABLE)TUB/SCRET RET RIGID ATTACH (July 26, 1990)
  • K900785 — MICRO 2 SYSTEM (April 16, 1990)
  • K896337 — DENTAL BRIDGE ANCHORING PINS (January 31, 1990)
  • K895986 — PRECISION DENTAL ATTACHMENTS (October 18, 1989)

FDA data resources