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510(k) K881394

NON-STERILE SUTURE NEEDLES by China National Medicines C/O Havel'S — Product Code GDL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 8, 1988
Date Received
April 4, 1988
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 for product code GDL

  • 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)
  • K812566 — UNIVERSAL SUTURE PASSER (November 10, 1981)