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510(k) K800404

MEDSPEC OPERATIVE OPTHALMIC KIT by Medi-Spec — Product Code HMP

K800404 is an FDA 510(k) premarket notification submitted by Medi-Spec for the device "MEDSPEC OPERATIVE OPTHALMIC KIT". The FDA issued a decision of Substantially Equivalent on April 24, 1980. The device falls under product code HMP (Pad, Eye), a Class I device regulated under 21 CFR 878.4440. Medi-Spec has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 24, 1980
Date Received
February 26, 1980
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 Medi-Spec

  • K833068 — LAMINARIA JAPONICA CERVICAL DILATOR (February 4, 1984)
  • K812694 — WHISK-R (October 26, 1981)
  • K812426 — UTERINE ASPIRATION CURETTES(RIGID&FLEX) (October 8, 1981)
  • K801554 — STERILE CAST PADDING (August 4, 1980)
  • K800490 — STERILE DRESSING PACK (March 12, 1980)
  • K790952 — CLAMP COVERS (June 5, 1979)
  • K780548 — DISPOSA-LOOPS (August 21, 1978)

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)
  • 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)

FDA data resources