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510(k) K823901

TREPHINE BLADES-VARIOUS MODELS by Edward Weck, Inc. — Product Code HRG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 17, 1983
Date Received
December 30, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Engine, Trephine, Accessories, Ac-Powered
Device Class
Class I
Regulation Number
886.4070
Review Panel
OP
Submission Type

Other clearances by Edward Weck, Inc.

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  • K911915 — HEMOCLIP II (January 9, 1992)
  • 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 HRG

  • K013151 — ASMOTOM AUTOMATED TREPHINE SYSTEM (December 14, 2001)
  • K981063 — AUTOMATED CORNEAL TREPHINE (June 23, 1998)
  • K843957 — ULTRATHIN/SP LENS (July 31, 1985)
  • K841515 — SCANLAN VASCU-STATT II (June 5, 1984)
  • K791763 — (MICRO-KERATRON, MICRO DUCT TREPHINE) (November 5, 1979)