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510(k) K930884

MEDICAL PROCEDURE TRAY, MODIFICATION by Enpak Medical Corp. — Product Code LDQ

K930884 is an FDA 510(k) premarket notification submitted by Enpak Medical Corp. for the device "MEDICAL PROCEDURE TRAY, MODIFICATION". The FDA issued a decision of Substantially Equivalent on March 21, 1995.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 21, 1995
Date Received
February 17, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

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  • K981032 — PIV SYSTEM (September 2, 1998)
  • K973747 — CONTROLLED TEMPERATURE CABINET SYSTEM (May 7, 1998)
  • K955661 — ACU-HALT (December 30, 1996)
  • K955776 — ACU-LAB (June 5, 1996)
  • K945374 — ACU-HALT (August 9, 1995)
  • K944961 — PERSONAL ALARM SYSTEM (PAS) (August 7, 1995)
  • K942810 — PALCO LABS COLD POUCH (June 28, 1995)
  • K934703 — MEDICOOL PROTECTALL (January 26, 1994)

FDA data resources