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510(k) K913102

PETERS CARDIONYL(TM) SUTURE by Promedica Products, Inc. — Product Code GAR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 3, 1992
Date Received
July 12, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Suture, Nonabsorbable, Synthetic, Polyamide
Device Class
Class II
Regulation Number
878.5020
Review Panel
SU
Submission Type

Other clearances by Promedica Products, Inc.

  • K913101 — PETERS CARDIOFLON(TM) SUTURE (August 12, 1992)
  • K892768 — PATIENT EXAMINATION GLOVES (POLY) (June 14, 1989)
  • K883412 — THE CARPENTIER TRANS-MITRAL VENTRICULAR VENT(TM) (February 8, 1989)
  • K882882 — C-MASK (August 10, 1988)
  • K882883 — C-MASK(FLAT) (August 10, 1988)

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  • K192420 — Crownjun Nylon Suture (May 29, 2020)
  • K161633 — REXLON, REXSIL (March 2, 2017)
  • K151165 — Aesculap Dafilon Nonabsorbable Polyamide Surgical Suture (February 17, 2016)
  • K152795 — RiverLon (Nylon) Suture (October 28, 2015)
  • K123034 — VITAL SUTURES SUTUREX CIRUGIA PERUANA SUTUMED (May 28, 2013)
  • K081366 — KUMAR T-ANCHORS HERNIA SET (July 15, 2008)
  • K060471 — FSSB NYLON SURGICAL SUTURES (July 26, 2006)