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510(k) K820140

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

K820140 is an FDA 510(k) premarket notification submitted by Stan-Pak Ent. for the device "WEBRIL CAST PADDING". The FDA issued a decision of Substantially Equivalent on February 12, 1982. The device falls under product code ITG (Bandage, Cast), a Class I device regulated under 21 CFR 890.3025. Stan-Pak Ent. has at least 10 other 510(k) clearances on record.

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)
  • K820155 — SPECIALIST CAST PADDING (February 12, 1982)
  • K820106 — X-RAY GUAZE SPONGES (February 12, 1982)
  • K820108 — TOPPER SPONGES (February 12, 1982)
  • K820107 — GUAZE SPONGES, PLAIN (February 12, 1982)
  • K820105 — COMBINE PAD OR ABD (February 5, 1982)
  • K820056 — TELFA STRIPS (February 5, 1982)
  • K820142 — TUBULAR STOCKINETTE (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)

FDA data resources