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510(k) K933503

PRO-PHACO HANDPIECE by M. Imonti and Associates Inc., — Product Code HQC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 6, 1994
Date Received
July 19, 1993
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 M. Imonti and Associates Inc.,

  • K950800 — PRO-PAK FOR OMS DIPLOMATE (May 22, 1995)
  • K950799 — PRO-VIT (April 28, 1995)
  • K933627 — PHACOFRAGMENTOR TIP (January 25, 1994)
  • K924551 — ENDO TRACHEA TUBE FIXATION (December 8, 1992)
  • K905766 — DRAINAGE TUBE RESTRAINT/WOUND COVER (March 6, 1991)

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