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510(k) K843592

VICO MICRO SURGICAL INSTRUMENTS by Visitec Co. — Product Code HWQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 5, 1984
Date Received
September 12, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Passer
Device Class
Class I
Regulation Number
888.4540
Review Panel
OR
Submission Type

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  • K945172 — VISITEC SILICONE RETINAL IMPLANTS/EXPLANTS (January 17, 1995)
  • K942234 — VISITEC PRECISE-POINT (July 12, 1994)
  • K934269 — FIBEROPTIC ILLUMINATED INSTRUMENTS (May 17, 1994)
  • K940210 — VISITEC EYE PAD (March 7, 1994)
  • K933872 — VISI-SPEAR EYE SPONGE (December 27, 1993)
  • K923972 — OPHTHALMIC FLUID DISTRIBUTION SETS (November 4, 1992)
  • K922530 — VISITEC MICROSURGICAL SUTURE (October 20, 1992)

Other clearances for product code HWQ

  • K970360 — MITEK SUTURE RETROGRADER (March 10, 1997)
  • K920621 — ACUFEX PASSING PINS AND SURGICAL WIRE (May 5, 1993)
  • K923381 — SOFT TISSUE EXPANDER (May 5, 1993)
  • K885311 — MENISCUS MENDER II LOOP (February 9, 1989)
  • K841623 — SLOTTED SOFT-TISSUE INSTRUMENT (July 11, 1984)
  • K841622 — SOFT-TISSUE INSTRUMENT (July 11, 1984)
  • K811679 — SILASTIC TENDON PASSER H.P. (July 10, 1981)
  • K791960 — ROTH-KENNEDY PASSER (October 4, 1979)