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510(k) K854809

WHITE CROSS STERILE PAD 4IN. X 4IN. by American White Cross, Inc.

K854809 is an FDA 510(k) premarket notification submitted by American White Cross, Inc. for the device "WHITE CROSS STERILE PAD 4IN. X 4IN.". The FDA issued a decision of Substantially Equivalent on January 13, 1986. American White Cross, Inc. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 13, 1986
Date Received
December 3, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Other clearances by American White Cross, Inc.

  • K964614 — ULTRAFERA WOUND DRESSING (February 6, 1997)
  • K962400 — AIR MAX EXTERNAL NASAL DILATOR STRIP (September 9, 1996)
  • K894802 — AWC BUTTERFLY WOUND CLOSURES (January 31, 1990)
  • K853558 — DOSIMETRIC RELEASE/RADIATION STERILIZ. ABSORB GAUZ (September 5, 1985)
  • K853334 — NON-ADHERA ADHESIVE PAD 3X4 (August 21, 1985)
  • K852408 — EXTRA LARGE ADHESIVE STRIPS (July 29, 1985)
  • K852412 — NON-ADHERENT PAD (July 29, 1985)
  • K852462 — TRICOT ADHESIVE BANDAGE (July 26, 1985)
  • K850595 — 3 X 4 NON-ADHERENT PAD (March 11, 1985)

FDA data resources