Home / 510(k) Clearances / K990355

510(k) K990355

STAINLESS STEEL SOFT SUTURE WIRE by Bregma International Trading Company , Ltd. — Product Code LRN

K990355 is an FDA 510(k) premarket notification submitted by Bregma International Trading Company , Ltd. for the device "STAINLESS STEEL SOFT SUTURE WIRE". The FDA issued a decision of Substantially Equivalent on July 8, 1999. The device falls under product code LRN (Wire, Surgical), a Class II device regulated under 21 CFR 888.3030. Bregma International Trading Company , Ltd. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 8, 1999
Date Received
February 5, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Wire, Surgical
Device Class
Class II
Regulation Number
888.3030
Review Panel
OR
Submission Type

Other clearances by Bregma International Trading Company , Ltd.

  • K990351 — BONE SCREWS (June 1, 1999)
  • K990353 — STAINLESS STEEL FIXATION PINS (June 1, 1999)

Other clearances for product code LRN

  • K002755 — NON-ABSORBING STERNATOMY MONOFILAMENT SUTURE (December 4, 2000)
  • K971682 — J-FX CERCLAGE SYSTEM (June 27, 1997)
  • K952783 — OXBORO-MEDICAL PIN COVERS (September 15, 1995)
  • K942603 — ORTHOPAEDIC WIRES (November 9, 1994)
  • K900926 — TROCHANTER CABLE GRIP SYSTEM (ADD'L INDICATIONS) (April 23, 1990)
  • K892651 — SONGER WIRING SYSTEM (July 25, 1989)
  • K864375 — TYPE 316L COTTER WIRE (May 20, 1987)

FDA data resources