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510(k) K760817

ORTHOPEDIC TUBULAR STOCKINETTE by Parke-Davis Co. — Product Code ILG

K760817 is an FDA 510(k) premarket notification submitted by Parke-Davis Co. for the device "ORTHOPEDIC TUBULAR STOCKINETTE". The FDA issued a decision of Substantially Equivalent on October 20, 1976. The device falls under product code ILG (Stocking, Elastic), a Class I device regulated under 21 CFR 890.3475. Parke-Davis Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 20, 1976
Date Received
October 12, 1976
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stocking, Elastic
Device Class
Class I
Regulation Number
890.3475
Review Panel
PM
Submission Type

Other clearances by Parke-Davis Co.

  • K861725 — INTRACATH INTRAVENOUS CATHETER PLACEMENT UNIT (December 4, 1986)
  • K862119 — DESERET FLO-THRU INJECTATE TEMPERATURE SENSOR (August 29, 1986)
  • K855120 — ATI DISPOSABLE BIOLOGICAL TEST PACK (June 18, 1986)
  • K860570 — ANGIO-FLO CONTINUOUS ARTERIAL CATH FLUSH DEVICE (March 31, 1986)
  • K860290 — VIAPIC CENTRAL LINE CATHETER (March 18, 1986)
  • K852192 — DISPOSABLE STEAM BIOLOGICAL TEST PACK (November 1, 1985)
  • K841967 — DESERET THERMODILUTION CARDIAC OUTPUT (August 19, 1985)
  • K851327 — DESERET ARTERIAL CATHETER (June 14, 1985)
  • K852078 — SPECTRUM(TENTATIVE) (June 7, 1985)
  • K844840 — DESERET INTRODUCER SET (May 16, 1985)

Other clearances for product code ILG

  • K833437 — ORTHOPEDIC STOCKINETTE (November 3, 1983)
  • K831540 — COMPRESSOGRIP ELASTIC STUMP SHRINKER# (June 8, 1983)
  • K780612 — STOCKINETTE, STERILE (April 19, 1978)
  • K780547 — STERILE ORTHOPEDIC STOCKINETTE (April 10, 1978)
  • K770346 — ORTHOPEDIC STOCKINETTE (March 7, 1977)
  • K770173 — STOCKINETTE (February 8, 1977)
  • K760576 — TOURNIWRAP BANDAGE (October 5, 1976)

FDA data resources