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510(k) K760576

TOURNIWRAP BANDAGE by Richard'S Medical Equip., Inc. — Product Code ILG

K760576 is an FDA 510(k) premarket notification submitted by Richard'S Medical Equip., Inc. for the device "TOURNIWRAP BANDAGE". The FDA issued a decision of Substantially Equivalent on October 5, 1976. The device falls under product code ILG (Stocking, Elastic), a Class I device regulated under 21 CFR 890.3475. Richard'S Medical Equip., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 5, 1976
Date Received
September 3, 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 Richard'S Medical Equip., Inc.

  • K830793 — PATIENT GUIDED ELBOW & SHOULDER EXERC (June 16, 1983)
  • K823837 — RMC TOTAL KNEE SYSTEM (March 29, 1983)
  • K823723 — SPECTRON PROXIMAL FEMORAL PROSTHESIS (March 9, 1983)
  • K823726 — SPECTRON CONVERSION ENDOPROSTHESIS CUP (March 9, 1983)
  • K823724 — SPECTRON NECK REPLACEMENT PROSTHESIS (March 9, 1983)
  • K823722 — SPECTRON LONG, STRAIGHT FEMORAL PROSTHES (March 8, 1983)
  • K823727 — SPECTRON PRIMARY STEM FEMORAL PROSTHES (March 8, 1983)
  • K830153 — RICHARDS INTRA-ARTICULAR SHAVER BLADES (February 28, 1983)
  • K830154 — COLLES FRACTURE FRAME (February 2, 1983)
  • K823725 — SPECTRON PROTRUSIO CUP (January 21, 1983)

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)
  • K760817 — ORTHOPEDIC TUBULAR STOCKINETTE (October 20, 1976)

FDA data resources