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510(k) K813219

CARAFLEX ELASTIC POLYMER PLASTER BANDA by Carapace, Inc. — Product Code ITG

K813219 is an FDA 510(k) premarket notification submitted by Carapace, Inc. for the device "CARAFLEX ELASTIC POLYMER PLASTER BANDA". The FDA issued a decision of Substantially Equivalent on December 17, 1981. The device falls under product code ITG (Bandage, Cast), a Class I device regulated under 21 CFR 890.3025. Carapace, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 17, 1981
Date Received
November 9, 1981
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 Carapace, Inc.

  • K931722 — CARAPACE LABOR AND DELIVERY SETS (March 23, 1994)
  • K931822 — CARAPACE PELVIC EXAM TRAYS (March 7, 1994)
  • K931729 — I.V. START KIT (February 22, 1994)
  • K931820 — CARAPACE STILLWATER BOWL SET (February 7, 1994)
  • K931669 — CARAPACE DEBRIDEMENT KITS (February 7, 1994)
  • K931760 — CARAPACE PACKING GAUZE TRAYS (February 4, 1994)
  • K932653 — SWISSTEK 2000(TM) CAST REMOVAL SYSTEM (January 28, 1994)
  • K931819 — CARAPACE SUTURE REMOVAL TRAYS (January 26, 1994)
  • K931758 — CARAPACE WOUND DRESSING KITS & LACERATION TRAYS (January 26, 1994)
  • K931759 — CARAPACE STERILE GAUZE TRAYS (January 25, 1994)

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