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510(k) K833734

NEUROLOGICAL SPONGE ON PLASTIC STICK by American Medical Disposable, Inc.

K833734 is an FDA 510(k) premarket notification submitted by American Medical Disposable, Inc. for the device "NEUROLOGICAL SPONGE ON PLASTIC STICK". The FDA issued a decision of Substantially Equivalent on April 23, 1984. American Medical Disposable, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 23, 1984
Date Received
October 25, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Other clearances by American Medical Disposable, Inc.

  • K833735 — AN ODOR ABSORBENT BANDAGE (April 23, 1984)
  • K833730 — NON ADHERENT BANDAGE/SHEET (January 27, 1984)
  • K833731 — BREATHABLE OVERWRAY BANDAGE NON-ELAS (January 27, 1984)
  • K833729 — ELASTIC BREATHABLE OVER-WRAP BANDAGE (December 30, 1983)
  • K833733 — NON - ADHERENT BANDAGE (December 27, 1983)
  • K833732 — NON WETTING UNDERCAST PADDING (December 12, 1983)
  • K830201 — POLYESTER X-RAY DETECTABLE STRUNG-SPONGE (February 23, 1983)
  • K830202 — COTTON BALLS, X-RAY OPAQUED STRUNG & NON (February 23, 1983)
  • K803116 — HEAVY DRAINAGE PACK (January 28, 1981)
  • K803115 — DRESSING CHANGE FOR G TUBE (January 6, 1981)

FDA data resources