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510(k) K921349

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

K921349 is an FDA 510(k) premarket notification submitted by Deroyal Industries, Inc. for the device "STERILE,DISPOSABLE EYE DRESSING". The FDA issued a decision of Substantially Equivalent on May 29, 1992. The device falls under product code HMP (Pad, Eye), a Class I device regulated under 21 CFR 878.4440. Deroyal Industries, Inc. has at least 10 other 510(k) clearances on record.

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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  • K193027 — Esophageal Stethoscope 9 French, Esophageal Stethoscope 12 French, Esophageal St (April 2, 2020)
  • K191425 — Hydro-Temp Neonatal Skin Temperature Probe Cover (January 21, 2020)
  • K173072 — Algidex Ag Silver Alginate Wound Dressing (April 4, 2018)
  • K171475 — DeRoyal Laprador Specimen Retrieval System (August 17, 2017)
  • K152978 — DeRoyal Angiography Kits (March 25, 2016)

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)
  • K850005 — VISOPROTECT OCCULAR SHIELD (March 20, 1985)
  • K850099 — VISOPROTECT: OCCULAR SHIELD (March 20, 1985)

FDA data resources