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510(k) K830430

EYELID SPECULUM by Douglas C. Mckee & Co. — Product Code HNC

K830430 is an FDA 510(k) premarket notification submitted by Douglas C. Mckee & Co. for the device "EYELID SPECULUM". The FDA issued a decision of Substantially Equivalent on June 10, 1983. The device falls under product code HNC (Specula, Ophthalmic), a Class I device regulated under 21 CFR 886.4350.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 10, 1983
Date Received
February 9, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Specula, Ophthalmic
Device Class
Class I
Regulation Number
886.4350
Review Panel
OP
Submission Type

Other clearances for product code HNC

  • K022836 — STEPHENS DISPOSABLE SPECULUM (November 1, 2002)
  • K981235 — OCULOSTAT (July 15, 1998)
  • K964289 — EYE FIXATION SPECULUM (December 17, 1996)
  • K863989 — THORNTON TITANIUM SPECULUM (MODIFIED BARRAQUER) (October 31, 1986)
  • K863664 — OPHTHALMIC SURGICAL SPECULUM (September 25, 1986)
  • K843196 — VISITEC EYE SPECULUM (October 5, 1984)
  • K801969 — ASNIS GUIDED SCREW SYSTEMS (August 27, 1980)
  • K760848 — FELDSTEIN BLEPHAROPLASTY CLIP RECTANGU (November 2, 1976)
  • K760849 — FELDSTEIN BLEPHAROSTOMY CLIP SQUARE (November 2, 1976)
  • K760847 — FELDSTEIN BLEPHAROPLASTY CLIP SHARP P (November 2, 1976)

FDA data resources