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510(k) K832826

AAP DOSIMETRY RELEASE OR BASIN SETS by American Hospital Supply Corp. — Product Code FNY

K832826 is an FDA 510(k) premarket notification submitted by American Hospital Supply Corp. for the device "AAP DOSIMETRY RELEASE OR BASIN SETS". The FDA issued a decision of Substantially Equivalent on April 23, 1984. The device falls under product code FNY (Basin, Emesis), a Class I device regulated under 21 CFR 880.6730. American Hospital Supply Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 23, 1984
Date Received
August 19, 1983
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 American Hospital Supply Corp.

  • K854739 — AMERICAN STERILE SURGICAL ABSORBENT TOWEL (December 27, 1985)
  • K854759 — AMERICAN STERILE MAYO STAND TRAY (December 17, 1985)
  • K830546 — DOSIMETRIC RELEASE (May 25, 1983)
  • K822990 — CONVERTORS PRIMARY WOUND DRESSING II (April 12, 1983)
  • K830343 — CONTAINER W/PRIMING SOLUTION (March 17, 1983)
  • K830301 — STRATUS FLUOROMETRIC ENZYME IMMUN0- (February 25, 1983)
  • K822755 — LATEX PENROSE TUBING (January 21, 1983)
  • K823418 — HEYER-SCHUTE UNIVERSAL URETERAL STENT (December 3, 1982)
  • K822966 — CONVERTORS DISPOSABLE DRESSING SPONGE (November 5, 1982)
  • K822754 — EAR/ULCER SYRINGE (October 4, 1982)

Other clearances for product code FNY

  • K802538 — BASIN PACK (October 31, 1980)
  • K800440 — STERILE SPONGE BOWLS (April 29, 1980)
  • K792625 — STERILIZATION PROCESS/PLACENTA BASIN (January 16, 1980)
  • K771733 — 8 EMESIS BASIN (September 28, 1977)
  • K760494 — BASIN, ROUND WASH (November 12, 1976)
  • K760492 — BASIN, LARGE OR SMALL (November 12, 1976)
  • K760495 — BASIN, RECTANGULAR WASH (November 12, 1976)
  • K760085 — BASIN, STERILE (#3200) (July 20, 1976)

FDA data resources