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510(k) K870902

LOOK RETROBULBAR NEEDLES by Look, Inc. — Product Code HMX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 20, 1987
Date Received
March 5, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

Other clearances by Look, Inc.

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  • K926586 — REVISED LABELING FOR CHROMIC AND PLAIN GUT SUTURES (December 22, 1993)
  • K926587 — REVISED LABELING FOR NYLON SUTURE (POLYAMIDE) (December 17, 1993)
  • K926168 — SILK SUTURES-REVISED LABELING (December 17, 1993)
  • K926167 — POLYVIOLENE SUTURE-REVISED LABELING (December 17, 1993)
  • K926588 — REVISED LABELING FOR POLYPROPYLENE SUTURE (December 17, 1993)
  • K913530 — LOOK VISCODISSECTOR (October 21, 1991)
  • K903029 — STERILE BLACK MONOFILAMENT NYLON NON-ABSOR. SUTURE (October 25, 1990)
  • K903584 — POLYPROPYLENE NONABSORBABLE SURGICAL SUTURES (October 11, 1990)

Other clearances for product code HMX

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  • K970873 — ENDOSOFT SOFT TIP NEEDLE (20 GA. AND 19 GA.) (May 20, 1997)
  • K943932 — STERISEAL OPHTHALMIC CANNULA (January 18, 1995)
  • K942403 — INFUSION CANNULA (August 17, 1994)
  • K934844 — INTER TIP T (April 19, 1994)
  • K930113 — KIRWAN IRRIGATION/ASPIRATION HANDPIECE (February 17, 1994)
  • K921488 — ASPIRATING ENDO OCULAR PROBE W/ILLUMINATION (May 7, 1992)
  • K915074 — IRRIGATOR/ASPIRATOR PROBE (February 5, 1992)
  • K904074 — VITREORETINAL INFUSION CANNULA (February 26, 1991)