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510(k) K820155

SPECIALIST CAST PADDING by Stan-Pak Ent. — Product Code ITG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 12, 1982
Date Received
January 19, 1982
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 by Stan-Pak Ent.

  • K823058 — DOSOMETRIC RELEASE STERILIZATION (December 9, 1982)
  • K820100 — FROSTED GLASS SLIDES (March 4, 1982)
  • K820099 — TRACH TAPE (February 23, 1982)
  • K820107 — GUAZE SPONGES, PLAIN (February 12, 1982)
  • K820140 — WEBRIL CAST PADDING (February 12, 1982)
  • K820108 — TOPPER SPONGES (February 12, 1982)
  • K820106 — X-RAY GUAZE SPONGES (February 12, 1982)
  • K820105 — COMBINE PAD OR ABD (February 5, 1982)
  • K820141 — BIAS STOCKINETTE (February 5, 1982)
  • K820139 — SOF-ROL CAST PADDING (February 5, 1982)

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)
  • K831492 — YESONA PLASTER OF PARIS BANDAGE (June 30, 1983)
  • K820890 — URETHANE ORTHOPAEDIC CASTING TAPE (June 23, 1982)