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510(k) K022666

PDO (POLYDIOXANONE) MONOFILAMENT SYNTHETIC ABSORBABLE SUTURE U.S.P. by Arc Medical Supplies (Beijing) Co, Ltd. — Product Code NEW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 9, 2002
Date Received
August 9, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Suture, Surgical, Absorbable, Polydioxanone
Device Class
Class II
Regulation Number
878.4840
Review Panel
SU
Submission Type

Other clearances by Arc Medical Supplies (Beijing) Co, Ltd.

  • K022664 — PGA (POLYGLYCOLIC) SYNTHETIC ABSORBABLE SUTURE U.S.P. (September 10, 2002)
  • K000541 — SILK NONABSORBABLE SURGICAL SUTURES, USP (April 28, 2000)
  • K000542 — PLAIN AND CHRONIC GUT ABSORBABLE SURGICAL SUTURES, USP (April 28, 2000)
  • K000537 — POLYPROPYLENE NONABSORBABLE SURGICAL SUTURES, USP (April 27, 2000)
  • K000540 — POLYESTER NONABSORBABLE SURGICAL SUTURES, USP (April 27, 2000)
  • K000539 — NYLON NONABSORBABLE SURGICAL SUTURES, USP (April 27, 2000)

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