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510(k) K772381

RING HANDLE & RETRACTORS by Edward Weck, Inc. — Product Code KAL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 17, 1978
Date Received
December 27, 1977
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Retractor, Ent
Device Class
Class I
Regulation Number
874.4420
Review Panel
EN
Submission Type

Other clearances by Edward Weck, Inc.

  • K915378 — WECK TROCAR (June 29, 1992)
  • K914690 — LM15(TM), CATALOG NUMBER - 523821 (March 23, 1992)
  • 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 KAL

  • K870758 — SMALL MASTOID RETRACTOR (March 4, 1987)
  • K833604 — ADJUSTABLE FORK RETRACTOR (January 3, 1984)
  • K772392 — ALLPORT MASTOID RETRACTORS (January 17, 1978)
  • K760851 — CONVERSE ALTAR RETRACTOR (March 10, 1977)