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510(k) K892655

ACL DRILL GUIDE SYSTEM by Baxter Healthcare Corp — Product Code LXI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 28, 1989
Date Received
April 13, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Guide, Drill, Ligament
Device Class
Class I
Regulation Number
878.4820
Review Panel
OR
Submission Type

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Other clearances for product code LXI

  • K930573 — SYNVASIVE CERAMIC SUTTING BLOCK (April 7, 1994)
  • K910712 — VILLAN (VIDEO LIFT LINK ANALYSIS) (May 21, 1991)
  • K890445 — PERSONAL ALERT ASSIST DEVICE (May 19, 1989)
  • K882407 — BOW & ARROW DRILL GUIDE (September 6, 1988)
  • K881378 — PFIZER HOSPITAL PRODUCTS GROUP ACL DRILL GUIDE (June 17, 1988)
  • K880739 — DYONICS DRILL GUIDE/ISOMETER SYSTEM (March 21, 1988)
  • K854254 — TENSION-ISOMETER (November 15, 1985)