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510(k) K852424

ACUFEX COMPARATIVE SURGICAL KERATOMETER by Acufex Microsurgical, Inc. — Product Code HJB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 11, 1985
Date Received
June 7, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instrument, Measuring, Corneal Radius
Device Class
Class I
Regulation Number
886.1450
Review Panel
OP
Submission Type

Other clearances by Acufex Microsurgical, Inc.

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  • K961853 — PROLINE FAST PASS ARTHOSCOPIC NEEDLE PASSER (June 21, 1996)
  • K954246 — ACUFEX ENDOFIX ABSORBABLE INTERFERENCE SCREW (February 15, 1996)
  • K952535 — ACUFEX ENDOBUTTON TAPE (February 8, 1996)
  • K953276 — ACUFEX TAG DELIVERY SYSTEM (October 5, 1995)
  • K953459 — ACUFEX TAG ANCHOR (August 23, 1995)
  • K941740 — ACUFEX ROTATOR CUFF FIXATION BUTTON (June 30, 1995)
  • K944500 — ACUFEX PATELLAR BONE BLOCK SIZER (June 12, 1995)
  • K951859 — ACUFEX ENDOBUTTON PACK (June 9, 1995)
  • K946346 — ACUFEX TAG(R) BIOABSORBABLE ANCHORS (April 26, 1995)

Other clearances for product code HJB

  • K930444 — MARCO STANDARD KERATOMETERS (August 9, 1993)
  • K924779 — BURTON KERATOMETER - MODLE 2040 (April 5, 1993)
  • K864369 — LTS CORNEAL MICROSCOPE LASER TOMOGRAPHIC SCANNER (December 15, 1986)
  • K864037 — KERASCAN MODEL 2000 KERATOGRAPHIC AUTO ANALYZER (November 13, 1986)