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510(k) K873111

CONFORMA(TM) PLASTER BANDAGES by The Kendal Co. — Product Code ITG

K873111 is an FDA 510(k) premarket notification submitted by The Kendal Co. for the device "CONFORMA(TM) PLASTER BANDAGES". The FDA issued a decision of Substantially Equivalent on October 9, 1987. The device falls under product code ITG (Bandage, Cast), a Class I device regulated under 21 CFR 890.3025. The Kendal Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 9, 1987
Date Received
August 10, 1987
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 The Kendal Co.

  • K000087 — MARHUKAR TRIPLE LUMEN CATHETER, MODEL 12 FR (March 17, 2000)
  • K990500 — KENDALL ULTRAMER COUDE FOLEY CATHETER, MODEL 1416C, KENDALL CURITY COUDE FOLEY C (September 28, 1999)
  • K991758 — MONOJECT INSULIN SYRINGE (June 14, 1999)
  • K970969 — KENDALL CURITY SUPRAPUBIC CATHETER TRAY, KIT, & REPLACEMENT SET (April 23, 1997)
  • K951488 — KENDALL CURITY CATHETER PLUG WITH PROTECTIVE CAP (April 25, 1995)
  • K942664 — KENDALL MODEL 6325 SCD SEQUEL COMPRESSION SYSTEM (January 17, 1995)
  • K942774 — POLYSKIN(R) M.R. MOIST RESPONSIVE TRANSPARENT DRESSING (July 20, 1994)
  • K892434 — KENDALL CURITY OXYGEN MASK (August 15, 1989)
  • K892440 — KENDALL CURITY EXTENSION TUBES (July 24, 1989)
  • K892438 — KENDALL CURITY INTRAVASCULAR CUT DOWN TUBES (July 24, 1989)

Other clearances for product code ITG

  • 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)
  • K820140 — WEBRIL CAST PADDING (February 12, 1982)

FDA data resources