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510(k) K840694

LENS INSERTION GLIDE by Innovative Surgical Products, Inc. — Product Code KYB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 9, 1984
Date Received
February 16, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Lens, Guide, Intraocular
Device Class
Class I
Regulation Number
886.4300
Review Panel
OP
Submission Type

Other clearances by Innovative Surgical Products, Inc.

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  • K841072 — IRRIGATION, ASPIRATION TUBING SETS (March 29, 1984)
  • K832235 — DISPOSABLE VITRECTOMY HANDPIECE (September 29, 1983)
  • K821496 — DISPOSABLE IRRIGA/ASPIR. SYSTEM (June 22, 1982)
  • K820765 — PLEURAL DRAINAGE RESERVOIR (April 15, 1982)
  • K820680 — DISPOSABLE TUBING SETS (April 9, 1982)
  • K802973 — ISPVAC TM (December 19, 1980)
  • K801350 — ACUVAC(TM) SUCTION RESERVOIR 400CC AND (July 14, 1980)

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  • K983129 — DISPOSABLE MICROSTAAR INJECTOR (MODEL MSI-P1) (December 4, 1998)