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510(k) K843048

RING SUPPORTED TREPHINE FOR CORNEA TRANS by Precision Instruments, Inc. — Product Code HRH

K843048 is an FDA 510(k) premarket notification submitted by Precision Instruments, Inc. for the device "RING SUPPORTED TREPHINE FOR CORNEA TRANS". The FDA issued a decision of Substantially Equivalent on October 5, 1984. The device falls under product code HRH (Trephine, Manual, Ophthalmic), a Class I device regulated under 21 CFR 886.4350. Precision Instruments, Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 5, 1984
Date Received
August 3, 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

Other clearances by Precision Instruments, Inc.

  • K864520 — BARRON ROTARY BLADE TREPHINE USING HESSBURG-BARRON (January 20, 1987)
  • K860648 — BARRON TWIN BLADE TREPHINE FOR EPPIKARATOPHAKIA (March 25, 1986)
  • K801585 — HESSBURG-BFRRON TREPHINE (October 3, 1980)

Other clearances for product code HRH

  • K022843 — GAYHEART CORNEAL EXCISION DEVICE (November 1, 2002)
  • 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)
  • K843646 — STEINWAY MICRO-KERATO-TREPHINE (January 3, 1985)
  • K812723 — PEARCE CORNEAL TREPHINE (October 13, 1981)
  • K781411 — CORNEAL CUTTER AND ACCESSORIES (September 20, 1978)

FDA data resources