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510(k) K863989

THORNTON TITANIUM SPECULUM (MODIFIED BARRAQUER) by Keeler Instruments, Inc. — Product Code HNC

K863989 is an FDA 510(k) premarket notification submitted by Keeler Instruments, Inc. for the device "THORNTON TITANIUM SPECULUM (MODIFIED BARRAQUER)". The FDA issued a decision of Substantially Equivalent on October 31, 1986. The device falls under product code HNC (Specula, Ophthalmic), a Class I device regulated under 21 CFR 886.4350. Keeler Instruments, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 31, 1986
Date Received
October 14, 1986
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 by Keeler Instruments, Inc.

  • K181143 — Keeler TonoCare Tonometer (February 8, 2019)
  • K112093 — CRYOMATIC CRYO CONSOLE, DISPOSABLE CRYO PROBE, DISPOSABLE PROBE ADAPTER (December 8, 2011)
  • K093298 — PULSAIR INTELLIPUFF, PULSAIR DESKTOP MODEL 2414-P-2001, 2417-P-2000 (December 10, 2010)
  • K100500 — PSL CLASSIC SLIT LAMP (March 9, 2010)
  • K062412 — CRYOMATIC (November 6, 2006)
  • K060822 — VANTAGE INDIRECT OPHTHALMOSCOPE (May 23, 2006)
  • K032087 — KEELER WIDE ANGLE OPHTHALMOSCOPE MODEL 1130-P-5004 (November 26, 2003)
  • K992954 — KEELER CRYO MASTER & PROBES (December 21, 1999)
  • K990257 — KEELER PULSAIR 3000 NON CONTACT TONOMETER (March 25, 1999)
  • K973064 — KEELER TEARSCOPE-PLUS (April 7, 1998)

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)
  • K863664 — OPHTHALMIC SURGICAL SPECULUM (September 25, 1986)
  • K843196 — VISITEC EYE SPECULUM (October 5, 1984)
  • K830430 — EYELID SPECULUM (June 10, 1983)
  • K801969 — ASNIS GUIDED SCREW SYSTEMS (August 27, 1980)
  • K760849 — FELDSTEIN BLEPHAROSTOMY CLIP SQUARE (November 2, 1976)
  • K760848 — FELDSTEIN BLEPHAROPLASTY CLIP RECTANGU (November 2, 1976)
  • K760847 — FELDSTEIN BLEPHAROPLASTY CLIP SHARP P (November 2, 1976)

FDA data resources