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510(k) K854225

ALLERGAN I.S.P. MODEL 3000 OPHTHALMIC SURGICAL-SYS by Advanced Medical Technology, Inc. — Product Code HQC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 27, 1985
Date Received
October 18, 1985
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 Advanced Medical Technology, Inc.

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  • K862777 — MODEL A-8000 ULTRASONIC HANDPIECE CORD (August 11, 1986)
  • K852997 — RAPI - STAPH (August 19, 1985)
  • K853187 — ACRIDINE ORANGE FLUORESCENT STAIN (August 13, 1985)
  • K853081 — AURAMINE O FLUORESCENT MYCOBACTERIAL STAIN SET (August 13, 1985)

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