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510(k) K991223

ABSORBABLE SURGICAL GUT SUTURE, PLAIN AND CHRONIC AND SOFTCAT ABSORBABLE SURGICAL GUT SUTURE, PLAIN AND CHRONIC by Aesculap, Inc. — Product Code GAL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 30, 1999
Date Received
April 12, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Suture, Absorbable, Natural
Device Class
Class II
Regulation Number
878.4830
Review Panel
SU
Submission Type

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Other clearances for product code GAL

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  • K030227 — SUTURTEK FASTCLOSE SUTURING DEVICE (March 17, 2003)
  • K020597 — SERRALGUT (August 14, 2002)
  • K021043 — GRAMS ABSORBABLE SURGICAL GUT SUTURE PLAIN & CHROMIC (June 21, 2002)
  • K011105 — SUTURTEK FASTCLOSE FASCIA CLOSURE DEVICE (May 30, 2001)
  • K001299 — PLAIN AND CHROMIC GUT ABSORBABLE SURGICAL SUTURES USP (June 23, 2000)
  • K000542 — PLAIN AND CHRONIC GUT ABSORBABLE SURGICAL SUTURES, USP (April 28, 2000)