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510(k) K053636

MANI NEEDLE & SUTURE PACK (PGA ABSORBABLE) by Mani, Inc. — Product Code GAM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 14, 2006
Date Received
December 29, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Suture, Absorbable, Synthetic, Polyglycolic Acid
Device Class
Class II
Regulation Number
878.4493
Review Panel
SU
Submission Type

Other clearances by Mani, Inc.

  • K053637 — MANI NEEDLE & SUTURE PACK (NYLON) (May 19, 2006)
  • K053638 — MANI NEEDLE & SUTURE PACK (SILK) (May 19, 2006)
  • K050150 — MANI NEEDLE & SUTURE PACK (December 5, 2005)

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