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510(k) K962771

BURKE CONGENITAL THORACOSCOPY INSTRUMENTS by Pilling Weck, Inc. — Product Code DWS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 19, 1996
Date Received
July 16, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instruments, Surgical, Cardiovascular
Device Class
Class I
Regulation Number
870.4500
Review Panel
CV
Submission Type

Other clearances by Pilling Weck, Inc.

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  • K945520 — HEMOCLIP ECOSYSTEM (January 27, 1995)
  • K944552 — PILLING WECK M-20 DISPOSABLE AUTOMATIC HEMOCLIP (November 7, 1994)
  • K943719 — VISISTAT STAPLER (August 24, 1994)

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  • K955689 — RNS STERILE, DISPOSABLE DIGITAL ANGIOGRAPHIC TRAY (May 15, 1996)
  • K960139 — G.E. STERILE ANGIOGRAPHIC TRAY (April 19, 1996)
  • K960144 — G.E. STERILE CT BIOPSY TRAY (April 15, 1996)
  • K960143 — G.E. STERILE DIGITAL ANGIOGRAPHIC TRAY (April 9, 1996)
  • K934727 — REPLACEMENT PARTS FOR CPI 6888 LEAD TUNNELER (January 10, 1994)
  • K900379 — HYCULT DIAMOND CORONARY BYPASS KNIFE (March 19, 1990)
  • K896307 — INSULATION PAD (January 19, 1990)
  • K894738 — MODEL 6888 LEAD TUNNELER (September 13, 1989)