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510(k) K780154

NEEDLEHOLDER, MICROVASULAR 5 1/2 by Edward Weck, Inc. — Product Code HNM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 17, 1978
Date Received
January 30, 1978
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Needle, Ophthalmic Suturing
Device Class
Class I
Regulation Number
886.4350
Review Panel
OP
Submission Type

Other clearances by Edward Weck, Inc.

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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 HNM

  • K844448 — OMS/GONVERS RETINAL PERFORATOR (August 21, 1985)