Home / 510(k) Clearances / K850595

510(k) K850595

3 X 4 NON-ADHERENT PAD by American White Cross, Inc.

K850595 is an FDA 510(k) premarket notification submitted by American White Cross, Inc. for the device "3 X 4 NON-ADHERENT PAD". The FDA issued a decision of Substantially Equivalent on March 11, 1985. American White Cross, Inc. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 11, 1985
Date Received
February 15, 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)
  • K854809 — WHITE CROSS STERILE PAD 4IN. X 4IN. (January 13, 1986)
  • 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)

FDA data resources