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510(k) K905173

SPLASH GUARD by E.M. Adams — Product Code KYZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 25, 1991
Date Received
November 16, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Syringe, Irrigating (Non Dental)
Device Class
Class I
Regulation Number
880.6960
Review Panel
HO
Submission Type

Other clearances by E.M. Adams

  • K910468 — STERILE DISPOSABLE DRAPE(S) (March 21, 1991)
  • K873978 — DISPOSABLE BIPOLAR FORCEPS (November 23, 1987)
  • K850063 — INSTRUMENT POCKET (February 21, 1985)
  • K843724 — I.V. START KIT & OBSTETRICAL KIT (January 10, 1985)
  • K843783 — WET PACK (December 19, 1984)
  • K843782 — DRY TRAY (December 13, 1984)
  • K843723 — STERILE INSTRUMENT TRAYS-VARIOUS (October 23, 1984)
  • K843115 — STERILE SOLUTION BOWL (September 7, 1984)
  • K843116 — DISPOSABLE SKIN MARKING PEN (August 17, 1984)
  • K831841 — STERILE DISP. INSTRUMENT TRAYS (December 14, 1983)

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  • K960725 — MARPP PRESSURE MONITORING SYSTEM (July 15, 1996)
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