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510(k) K862115

DEKNA BAND KIT by Deknatel, Inc. — Product Code ITG

K862115 is an FDA 510(k) premarket notification submitted by Deknatel, Inc. for the device "DEKNA BAND KIT". The FDA issued a decision of Substantially Equivalent on August 19, 1986. The device falls under product code ITG (Bandage, Cast), a Class I device regulated under 21 CFR 890.3025. Deknatel, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 19, 1986
Date Received
June 3, 1986
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 Deknatel, Inc.

  • K963850 — PLEUR-EVAC SAHARA PLUS MODEL S-1150 CONTINUOUS REINFUSION AUTOTRANSFUSION SYSTEM (April 22, 1997)
  • K962683 — SNOWDEN-PENCER COMPUTERIZED HIGH FLOW INSUFFLATOR (January 10, 1997)
  • K964070 — DEKNATEL DSP PLEUR-EVAC AUTOTRANSFUSION BLOOD RECOVERY BAG (December 31, 1996)
  • K963098 — PLEUR-EVAC SHARA PLUS MODEL S-2150/CONTINUOUS REINFUSION AUTOTRANSFUSION SYSTEM( (November 8, 1996)
  • K962856 — PLEUR-EVAC SAHARA ADULT/PEDIATRIC CHEST DRAINAGE SYSTEM MODEL S-1100, S-1200, 2- (August 28, 1996)
  • K925243 — DEKNATEL(TM) PLEUR-EVAC(R) THORACIC CATHETER (July 27, 1994)
  • K930740 — SURGICAL SUTURE, NONABSORABLE STAINLESS STEEL (July 26, 1994)
  • K926338 — PLEUR-EVAC CARDIOTOMY RESERVOIR # CR-9400 & 9400F (July 26, 1994)
  • K930738 — SURGICAL SUTURES, PGL, GUT, DEKLENE, OPTHAMEND ETC (July 26, 1994)
  • K930739 — SUTURES POLYPROP., POLYETHELINE, NYLON & SILK (July 26, 1994)

Other clearances for product code ITG

  • K873111 — CONFORMA(TM) PLASTER BANDAGES (October 9, 1987)
  • 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)
  • K820155 — SPECIALIST CAST PADDING (February 12, 1982)

FDA data resources