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510(k) K921349

STERILE,DISPOSABLE EYE DRESSING by Deroyal Industries, Inc. — Product Code HMP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 29, 1992
Date Received
March 19, 1992
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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Other clearances for product code HMP

  • K940333 — EYE PAD (March 7, 1994)
  • K904896 — EYE PAD (December 5, 1990)
  • 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)