Home / 510(k) Clearances / K853558

510(k) K853558

DOSIMETRIC RELEASE/RADIATION STERILIZ. ABSORB GAUZ by American White Cross, Inc.

K853558 is an FDA 510(k) premarket notification submitted by American White Cross, Inc. for the device "DOSIMETRIC RELEASE/RADIATION STERILIZ. ABSORB GAUZ". The FDA issued a decision of Substantially Equivalent on September 5, 1985. American White Cross, Inc. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 5, 1985
Date Received
August 26, 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)
  • 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