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510(k) K041511

TRULENE NON-ABSORBABLE POLYPROPYLENE SURGICAL SUTURE by Sutures India Private Limited — Product Code GAW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 3, 2005
Date Received
June 7, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Suture, Nonabsorbable, Synthetic, Polypropylene
Device Class
Class II
Regulation Number
878.5010
Review Panel
SU
Submission Type

Other clearances by Sutures India Private Limited

  • K041514 — TRUESILK NON-ABSORBABLE SILK SURGICAL SUTURE (June 3, 2005)
  • K041512 — NONABSORBABLE (POLYETHYLENE TEREPHTHALATE) SURGICAL SUTURE (June 2, 2005)
  • K041510 — TRULON NON-ABSORBABLE POLYAMIDE SURGICAL SUTURE (June 2, 2005)
  • K041515 — TRUGLYDE ABSORBABLE POLYGLYCOLIC ACID SURGICAL SUTURE (April 8, 2005)

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