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510(k) K904896

EYE PAD by Ulti-Med Intl., Inc. — Product Code HMP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 5, 1990
Date Received
October 30, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pad, Eye
Device Class
Class I
Regulation Number
878.4440
Review Panel
SU
Submission Type

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  • K923176 — SURGICAL INSTRUMENT KIT, DISPOSABLE (June 17, 1993)
  • K920989 — SURGICAL INSTRUMENT KIT, DISPOSABLE (October 19, 1992)
  • K922828 — ULCER WOUND TRAY (September 28, 1992)
  • K914244 — STERILE CUSTOM SURGICAL KITS (February 24, 1992)
  • K914431 — ABSORBENT FIBER (December 4, 1991)
  • K912692 — CONFORMING BANDAGE (October 4, 1991)
  • K912693 — POST OPERATIVE SPONGE (October 4, 1991)
  • K901465 — ABSORBABLE GAUZE DRAPE (June 12, 1990)

Other clearances for product code HMP

  • K940333 — EYE PAD (March 7, 1994)
  • K921349 — STERILE,DISPOSABLE EYE DRESSING (May 29, 1992)
  • K883822 — FIRST AID KIT, EYE DRESSING NSN6545-00-853-6309 (November 22, 1988)
  • K874411 — DONALDSON NATURAL EYEPATCH 'PATIENT PAK' (January 27, 1988)
  • K864810 — LIDSPLINT (January 20, 1987)
  • K861456 — SHEETS LYOPHILIZED COLLAGEN HEYEDRATOR (July 25, 1986)
  • K860979 — DONALDSON NATURAL EYEPATCH (April 4, 1986)
  • K851906 — SURGICAL EYE PACK (May 21, 1985)
  • K850099 — VISOPROTECT: OCCULAR SHIELD (March 20, 1985)
  • K850005 — VISOPROTECT OCCULAR SHIELD (March 20, 1985)