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510(k) K831492

YESONA PLASTER OF PARIS BANDAGE by Watson Phillips Y Cia. Sucs., S.A. DE C.V. — Product Code ITG

K831492 is an FDA 510(k) premarket notification submitted by Watson Phillips Y Cia. Sucs., S.A. DE C.V. for the device "YESONA PLASTER OF PARIS BANDAGE". The FDA issued a decision of Substantially Equivalent on June 30, 1983. 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
June 30, 1983
Date Received
May 10, 1983
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)
  • K842573 — T.P.G. CAST TAPE (August 10, 1984)
  • 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)
  • K820890 — URETHANE ORTHOPAEDIC CASTING TAPE (June 23, 1982)
  • K820140 — WEBRIL CAST PADDING (February 12, 1982)

FDA data resources