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510(k) K930759

CP & S STERILE BURN SHEET by Consolidated Products & Services, Inc. — Product Code FPY

K930759 is an FDA 510(k) premarket notification submitted by Consolidated Products & Services, Inc. for the device "CP & S STERILE BURN SHEET". The FDA issued a decision of Substantially Equivalent on January 21, 1994. The device falls under product code FPY (Sheet, Burn), a Class I device regulated under 21 CFR 880.5180. Consolidated Products & Services, Inc. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 21, 1994
Date Received
February 12, 1993
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 Consolidated Products & Services, Inc.

  • K974190 — CP&S INSTANT COLD PACK LIMB KIT TRANSPORTER (November 19, 1997)
  • K890550 — CP&S DISPOSABLE URINARY LEGBAG (MEDIUM & LARGE) (February 28, 1989)
  • K890551 — URINARY DRAINAGE UNIT (February 28, 1989)
  • K890552 — CP&S GAVAGE CONSTAINER, DISPOSABLE (February 24, 1989)
  • K890554 — CP&S DISPOSABLE INSTANT SUPER HOT COMPRESS (February 13, 1989)
  • K890553 — CP&S DISPOSABLE INSTANT COLD COMPRESS (February 13, 1989)

Other clearances for product code FPY

  • K921471 — BURNSHIELD TRAUMA DRESSING (April 20, 1993)
  • K926290 — BURN SHEET (April 20, 1993)
  • K921470 — BURNSHIELD FIRE BLANKET (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)
  • K820994 — ABSORB FURN SHEET (May 13, 1982)

FDA data resources