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510(k) K841898

FIRST RESPONSE EMERG. MEDICSL - BURNS by Reed Products, Inc. — Product Code FPY

K841898 is an FDA 510(k) premarket notification submitted by Reed Products, Inc. for the device "FIRST RESPONSE EMERG. MEDICSL - BURNS". The FDA issued a decision of Substantially Equivalent on August 14, 1984. The device falls under product code FPY (Sheet, Burn), a Class I device regulated under 21 CFR 880.5180. Reed Products, Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 14, 1984
Date Received
May 7, 1984
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 Reed Products, Inc.

  • K841897 — FIRST RESPONSE EMERG. MEDICAL SYSTEM (July 23, 1984)
  • K841900 — FIRST RESPONSE EMERG. EYE INJURIES (July 23, 1984)
  • K841899 — FIRST RESPONSE EMERG. MEDICAL SYS BONES (July 23, 1984)

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)
  • K820994 — ABSORB FURN SHEET (May 13, 1982)

FDA data resources