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510(k) K850338

EMERGENCY ROOM PACK by Marwood Medical, Inc.

K850338 is an FDA 510(k) premarket notification submitted by Marwood Medical, Inc. for the device "EMERGENCY ROOM PACK". The FDA issued a decision of Substantially Equivalent on March 25, 1985. Marwood Medical, Inc. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 25, 1985
Date Received
January 28, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Other clearances by Marwood Medical, Inc.

  • K850340 — EYE PROCEDURE PACK (May 22, 1985)
  • K850339 — SPECIAL PROCEDURES PACK (March 12, 1985)
  • K850341 — CARDIOVASCULAR SET UP (February 25, 1985)
  • K850337 — CARDIAC CATHETERIZATION PACK (February 25, 1985)
  • K840620 — TPN/CVP DRESSING CHANGE KIT (May 30, 1984)
  • K840619 — I.V. START KIT (March 27, 1984)

FDA data resources