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510(k) K910468

STERILE DISPOSABLE DRAPE(S) by E.M. Adams — Product Code FZI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 21, 1991
Date Received
February 4, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Apparatus, Air Handling, Enclosure
Device Class
Class II
Regulation Number
878.5070
Review Panel
SU
Submission Type

Other clearances by E.M. Adams

  • K905173 — SPLASH GUARD (April 25, 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)

Other clearances for product code FZI

  • K911132 — MULTIPLE, SURGICAL DRAPE PACK (May 6, 1991)
  • K854159 — ELLIPTI-PUNCH (November 15, 1985)
  • K772395 — DAVIS RHYTIDECTOMY (March 9, 1978)
  • K772394 — KALRN FACE-LIFE SCISSORS (March 9, 1978)