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510(k) K883822

FIRST AID KIT, EYE DRESSING NSN6545-00-853-6309 by Consolidated Industries of Greater Syracuse, Inc. — Product Code HMP

K883822 is an FDA 510(k) premarket notification submitted by Consolidated Industries of Greater Syracuse, Inc. for the device "FIRST AID KIT, EYE DRESSING NSN6545-00-853-6309". The FDA issued a decision of Substantially Equivalent (with conditions) on November 22, 1988. The device falls under product code HMP (Pad, Eye), a Class I device regulated under 21 CFR 878.4440.

Clearance Details

Decision
SESD (Substantially Equivalent (with conditions))
Decision Date
November 22, 1988
Date Received
September 7, 1988
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 for product code HMP

  • K940333 — EYE PAD (March 7, 1994)
  • K921349 — STERILE,DISPOSABLE EYE DRESSING (May 29, 1992)
  • K904896 — EYE PAD (December 5, 1990)
  • 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