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510(k) K890445

PERSONAL ALERT ASSIST DEVICE by Silent Call Corp. — Product Code LXI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 19, 1989
Date Received
January 27, 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

Other clearances by Silent Call Corp.

  • K890596 — MED-A-CALL ASSIST DEVICE (March 14, 1989)

Other clearances for product code LXI

  • K930573 — SYNVASIVE CERAMIC SUTTING BLOCK (April 7, 1994)
  • K910712 — VILLAN (VIDEO LIFT LINK ANALYSIS) (May 21, 1991)
  • K892655 — ACL DRILL GUIDE SYSTEM (September 28, 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)