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510(k) K792294

BREAST PAD by American Hospital Supply Corp. — Product Code FRL

K792294 is an FDA 510(k) premarket notification submitted by American Hospital Supply Corp. for the device "BREAST PAD". The FDA issued a decision of Substantially Equivalent on December 11, 1979. The device falls under product code FRL (Fiber, Medical, Absorbent), a Class I device regulated under 21 CFR 880.5300. American Hospital Supply Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 11, 1979
Date Received
November 13, 1979
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Fiber, Medical, Absorbent
Device Class
Class I
Regulation Number
880.5300
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)
  • K832826 — AAP DOSIMETRY RELEASE OR BASIN SETS (April 23, 1984)
  • 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)

Other clearances for product code FRL

  • K121898 — STAY FRESH SKIN FOLD MANAGEMENT TEXTILE (May 24, 2013)
  • K110715 — INTERDRY SILVER (November 4, 2011)
  • K061615 — INTERDRY TEXTILE WITH SILVER (December 22, 2006)
  • K931626 — CARAPACE STERILE COTTON BALLS (December 2, 1993)
  • K914081 — ICAN COTTON RAYON BALLS (October 9, 1991)
  • K811990 — TRACH CLEANING TRAY (July 27, 1981)
  • K810242 — UTENSIL & PROCEDURE TRAYS (April 15, 1981)
  • K800277 — MEDSPEC RAYON BALLS (March 12, 1980)
  • K800249 — SURGITEK FOERSTER MAMMARY BANDAGE (February 19, 1980)
  • K800248 — SURGITEK FOERSTER FACE LIFT BANDAGE (February 19, 1980)

FDA data resources