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510(k) K843646

STEINWAY MICRO-KERATO-TREPHINE by Steinway Instrument Co., Inc. — Product Code HRH

K843646 is an FDA 510(k) premarket notification submitted by Steinway Instrument Co., Inc. for the device "STEINWAY MICRO-KERATO-TREPHINE". The FDA issued a decision of Substantially Equivalent on January 3, 1985. The device falls under product code HRH (Trephine, Manual, Ophthalmic), a Class I device regulated under 21 CFR 886.4350.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 3, 1985
Date Received
September 17, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

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  • K931792 — ARTHROSCOPE (June 13, 1994)
  • K873918 — HEAD & CHIN RESTS (October 28, 1987)
  • K864520 — BARRON ROTARY BLADE TREPHINE USING HESSBURG-BARRON (January 20, 1987)
  • K862524 — DEKNATEL (R) TREPHINE (August 11, 1986)
  • K861825 — CORNEAL TRANSPLANT TREPHINE DISPOSABLE BLADE (June 9, 1986)
  • K860648 — BARRON TWIN BLADE TREPHINE FOR EPPIKARATOPHAKIA (March 25, 1986)
  • K843048 — RING SUPPORTED TREPHINE FOR CORNEA TRANS (October 5, 1984)
  • K812723 — PEARCE CORNEAL TREPHINE (October 13, 1981)
  • K781411 — CORNEAL CUTTER AND ACCESSORIES (September 20, 1978)

FDA data resources