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510(k) K792378

HEMOSPENSER CARTRIDGE CAT. NO. 523500- by Edward Weck, Inc. — Product Code GDO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 6, 1979
Date Received
November 26, 1979
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Applier, Surgical, Clip
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
Submission Type

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  • K914470 — PNEUMO-SEAL(TM) (November 29, 1991)
  • K911272 — ENDOSCOPIC NEEDLHOLDER CAT. NUMBER 114705 (July 2, 1991)
  • K902108 — HEM-O-LOK(TM) (August 6, 1990)
  • K902232 — WECK ELECTROSURGICAL GENERATOR #174200 (August 2, 1990)
  • K897045 — BOWIE-DICK TEST CARD CATALOG NUMBER 008018 (February 15, 1990)
  • K871110 — CORONARY ARTERY BYPASS GRAFT (CABG) MARKER (August 27, 1987)
  • K851251 — AUTO/MANUAL TITANIUM HEMOCLIP LIGATING CLIP 527200 (July 2, 1985)

Other clearances for product code GDO

  • K926199 — UNICLIP SURGICAL CLIP APPLIER (April 20, 1993)
  • K890941 — MODIFIED SUTURE DISP. ENDOSCOPIC SURGICAL CLIP APP (April 7, 1989)
  • K890159 — TOWEL CLIPS (February 3, 1989)
  • K890233 — SUTURE CLIP APPLIER/REMOVER (January 27, 1989)
  • K820837 — DISPOSABLE MULTIPLE LIGATING CLIP (May 28, 1982)
  • K812291 — ETHICON MULTIPLE LIGATING CLIP APPLIER (September 11, 1981)
  • K791845 — BAYONET HEIFETZ CLIP APPLIERS (October 17, 1979)
  • K790855 — SURGICAL DRAPE CLIP #201 (August 3, 1979)
  • K791157 — 360 HEMOCLIP APPLIERS (June 27, 1979)
  • K790990 — REYNOLDS DOUBLE HEMOCLIP APPLIERS (June 5, 1979)