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510(k) K800440

STERILE SPONGE BOWLS by Premium Plastics, Inc. — Product Code FNY

K800440 is an FDA 510(k) premarket notification submitted by Premium Plastics, Inc. for the device "STERILE SPONGE BOWLS". The FDA issued a decision of Substantially Equivalent on April 29, 1980. The device falls under product code FNY (Basin, Emesis), a Class I device regulated under 21 CFR 880.6730. Premium Plastics, Inc. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 29, 1980
Date Received
February 28, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Basin, Emesis
Device Class
Class I
Regulation Number
880.6730
Review Panel
HO
Submission Type

Other clearances by Premium Plastics, Inc.

  • K953226 — PULM O2 SUCTION CATHETER TRAYS (August 8, 1995)
  • K950851 — GENT-L-KARE TRACHEOSTOMY TRAYS (June 21, 1995)
  • K950850 — GENT-L-KARE LACERATION TRAYS (March 14, 1995)
  • K943740 — ROLL-A-WAY SHARPS DISPOSAL SYSTEM (RED AND IVORY) (December 14, 1994)
  • K890107 — GENT-L-KARE(TM) STERILE, PRESSURE SORE MANAGE KIT (October 24, 1989)
  • K893135 — GENT-L-KARE STER SUCT CATH TRAY W/14 FR/STER WATER (June 22, 1989)
  • K850285 — GENT-L-KARE STERILE URETHRAL CATHETERIZATION TRAY (February 28, 1985)
  • K771448 — STERILE SUTURE REMOVAL KIT (September 6, 1977)

Other clearances for product code FNY

  • K832826 — AAP DOSIMETRY RELEASE OR BASIN SETS (April 23, 1984)
  • K802538 — BASIN PACK (October 31, 1980)
  • K792625 — STERILIZATION PROCESS/PLACENTA BASIN (January 16, 1980)
  • K771733 — 8 EMESIS BASIN (September 28, 1977)
  • K760495 — BASIN, RECTANGULAR WASH (November 12, 1976)
  • K760492 — BASIN, LARGE OR SMALL (November 12, 1976)
  • K760494 — BASIN, ROUND WASH (November 12, 1976)
  • K760085 — BASIN, STERILE (#3200) (July 20, 1976)

FDA data resources