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510(k) K812566

UNIVERSAL SUTURE PASSER by Ortho Pared Instruments, Inc. — Product Code GDL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 10, 1981
Date Received
September 9, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Needle, Suturing, Reusable
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
Submission Type

Other clearances by Ortho Pared Instruments, Inc.

  • K831772 — GUILLOTINE BLADE (July 7, 1983)
  • K820225 — MENISCUS EXTRACTOR (February 4, 1982)
  • K820226 — UNIVERSALL DRILL GUIDE (February 4, 1982)

Other clearances for product code GDL

  • K881394 — NON-STERILE SUTURE NEEDLES (April 8, 1988)
  • K851781 — 25-420 TO 25-436 VARIOUS TYPES OF SUTURE NEEDLES (June 20, 1985)
  • K851782 — 25-450 TO 25-540 VARIOUS SUTURE FORCEPS (June 20, 1985)
  • K813589 — SHARTPOINT EYED NEEDLES (January 18, 1982)