Home / 510(k) Clearances / K780418

510(k) K780418

BURN DRESSING PAD by The Owenby Co. — Product Code FPY

K780418 is an FDA 510(k) premarket notification submitted by The Owenby Co. for the device "BURN DRESSING PAD". The FDA issued a decision of Substantially Equivalent on April 10, 1978. The device falls under product code FPY (Sheet, Burn), a Class I device regulated under 21 CFR 880.5180. The Owenby Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 10, 1978
Date Received
March 14, 1978
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Sheet, Burn
Device Class
Class I
Regulation Number
880.5180
Review Panel
SU
Submission Type

Other clearances by The Owenby Co.

  • K801628 — RESTRAINT, PROTECTIVE (August 7, 1980)
  • K801626 — ARM SLING (July 28, 1980)
  • K801532 — STOCKINETTE, STERILE TWO PLY W/PULL TABS (July 28, 1980)
  • K801627 — COVER, LIMB (July 28, 1980)
  • K801531 — ARM SLING (July 21, 1980)
  • K790210 — STOCKINETTE, TUBULAR UNBLEACHED (February 27, 1979)
  • K780764 — NON-STERILE FOLDED GAUZE (June 6, 1978)
  • K770889 — BURN DRESSING KIT (July 11, 1977)
  • K761069 — P.S.M. BOTIQUE CAP (December 30, 1976)
  • K761068 — P.S.M. BOUFFANT CAP (December 30, 1976)

Other clearances for product code FPY

  • K930759 — CP & S STERILE BURN SHEET (January 21, 1994)
  • K921470 — BURNSHIELD FIRE BLANKET (April 20, 1993)
  • K926290 — BURN SHEET (April 20, 1993)
  • K921471 — BURNSHIELD TRAUMA DRESSING (April 20, 1993)
  • K900441 — BURNS CASUALTY SHEET (July 3, 1990)
  • K900443 — BURNS CASUALTY SHEET LIMB WRAP (July 3, 1990)
  • K900442 — BURNS CASUALTY SHEET BURN ROLL (July 3, 1990)
  • K871740 — LYOSHEET SURGICAL SHEET FOR BURNS (June 9, 1987)
  • K853145 — KENDALL CURITY BURN PAD (August 30, 1985)
  • K841898 — FIRST RESPONSE EMERG. MEDICSL - BURNS (August 14, 1984)

FDA data resources