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510(k) K990432

SURGISORB by Sutures , Ltd. — Product Code GAM

Clearance Details

Decision
SN ()
Decision Date
May 27, 1999
Date Received
February 11, 1999
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 Sutures , Ltd.

  • K953609 — PRODEK (January 31, 1996)
  • K943220 — SUTULENE (December 5, 1994)
  • K943216 — SURGIDEK (December 5, 1994)
  • K943217 — PLAIN CATGUT (December 5, 1994)
  • K943627 — SURGISILK (December 5, 1994)
  • K943223 — SURGIDEK B (December 5, 1994)
  • K943218 — CHROMIC CATGUT (December 5, 1994)
  • K943221 — SURGIBOND (December 5, 1994)
  • K943222 — SURGIDEK S (December 5, 1994)
  • K865038 — SURGISTEEL (June 30, 1987)

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