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510(k) K842573

T.P.G. CAST TAPE by The Poly Group, Inc. — Product Code ITG

K842573 is an FDA 510(k) premarket notification submitted by The Poly Group, Inc. for the device "T.P.G. CAST TAPE". The FDA issued a decision of Substantially Equivalent on August 10, 1984. The device falls under product code ITG (Bandage, Cast), a Class I device regulated under 21 CFR 890.3025.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 10, 1984
Date Received
July 3, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bandage, Cast
Device Class
Class I
Regulation Number
890.3025
Review Panel
PM
Submission Type

Other clearances for product code ITG

  • K873111 — CONFORMA(TM) PLASTER BANDAGES (October 9, 1987)
  • K862115 — DEKNA BAND KIT (August 19, 1986)
  • K840416 — HEXCELITE (March 23, 1984)
  • K833732 — NON WETTING UNDERCAST PADDING (December 12, 1983)
  • K832992 — SOFFBAN ORTHOPEDIC PADDING (November 14, 1983)
  • K832237 — ORTHOPEDIC CASTING TAPE MAXCAST (August 16, 1983)
  • K830650 — SUPPORT PRODUCTS EXAMPLE PROSET CAST (July 7, 1983)
  • K831492 — YESONA PLASTER OF PARIS BANDAGE (June 30, 1983)
  • K820890 — URETHANE ORTHOPAEDIC CASTING TAPE (June 23, 1982)
  • K820140 — WEBRIL CAST PADDING (February 12, 1982)

FDA data resources