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510(k) K904896

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

K904896 is an FDA 510(k) premarket notification submitted by Ulti-Med Intl., Inc. for the device "EYE PAD". The FDA issued a decision of Substantially Equivalent on December 5, 1990. The device falls under product code HMP (Pad, Eye), a Class I device regulated under 21 CFR 878.4440. Ulti-Med Intl., Inc. has at least 10 other 510(k) clearances on record.

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

Other clearances by Ulti-Med Intl., Inc.

  • K103011 — ULTICARE SAFETY INSULIN SYRINGE (February 2, 2011)
  • K923175 — SURGICAL INSTRUMENT KIT, DISPOSABLE (June 17, 1993)
  • 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)
  • K912693 — POST OPERATIVE SPONGE (October 4, 1991)
  • K912692 — CONFORMING BANDAGE (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)

FDA data resources