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510(k) K910067

PTI STERNAL CLOSURE WIRE SUTURE by Pioneering Technologies, Inc. — Product Code GAQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 6, 1991
Date Received
January 9, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile
Device Class
Class II
Regulation Number
878.4495
Review Panel
SU
Submission Type

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  • K901682 — PTI ANASTOMARK(TM) CORONARY BYPASS GRAFT MARKERS (July 3, 1990)
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  • K901531 — PTI INTRA-ARTR REUSABLE CORONARY ARTERY PROBE (June 20, 1990)
  • K901575 — REUSABLE TENS PARAVERTEBRAL PAD #641 BACK ELECTROD (May 2, 1990)
  • K897075 — PTI INTRA-ART(TM) ANSARI SAPHENOUS VEIN HOLDER (April 10, 1990)
  • K894684 — PTI INTRA-ART INTERNAL MAMMARY ARTERY CANNULA KIT (October 17, 1989)

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