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510(k) K961658

MEGATRON OPHTHALMIC SURGICAL SYSTEM by Intl. Ophthalmic Industries Corp. — Product Code HQC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 23, 1996
Date Received
April 29, 1996
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 Intl. Ophthalmic Industries Corp.

  • K894513 — DIATHRON(R) DIATHERMY UNIT (October 31, 1989)
  • K894511 — MAGNETRON MUNICH MODEL ELECTRONIC CONTROL UNIT (October 17, 1989)
  • K894512 — PHACOEMULSIFICATION UNIT TO REMOVE CATARAC. LENS (October 17, 1989)
  • K823088 — ASPITRON (April 6, 1983)
  • K791763 — (MICRO-KERATRON, MICRO DUCT TREPHINE) (November 5, 1979)

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