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510(k) K840695

PHACOEMULSIFICATION KITS by Innovative Surgical Products, Inc. — Product Code HQC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 22, 1984
Date Received
February 16, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Unit, Phacofragmentation
Device Class
Class II
Regulation Number
886.4670
Review Panel
OP
Submission Type

Other clearances by Innovative Surgical Products, Inc.

  • K843041 — HESLIN DISPOS. TUBING SET (November 21, 1984)
  • K840693 — DISPOSABLE SCLERAL GLOBE PLUG (May 22, 1984)
  • K840694 — LENS INSERTION GLIDE (May 9, 1984)
  • 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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