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510(k) K801468

FRAZIER-FERGUSON SUCTION TUBES by Edward Weck, Inc. — Product Code KCB

K801468 is an FDA 510(k) premarket notification submitted by Edward Weck, Inc. for the device "FRAZIER-FERGUSON SUCTION TUBES". The FDA issued a decision of Substantially Equivalent on August 12, 1980. The device falls under product code KCB (Tube, Tonsil Suction), a Class I device regulated under 21 CFR 874.4420. Edward Weck, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 12, 1980
Date Received
June 24, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tube, Tonsil Suction
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)

FDA data resources