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510(k) K905620

MODIFIED SITE PERISTALTIC FOOTSWITCH by Site Microsurgical Systems, Inc. — Product Code EBW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 27, 1991
Date Received
December 14, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Controller, Foot, Handpiece And Cord
Device Class
Class I
Regulation Number
872.4200
Review Panel
DE
Submission Type

Other clearances by Site Microsurgical Systems, Inc.

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  • K925921 — MODIFIED SITE DISPOSABLE DIAPHRAGM CASSETTE (December 6, 1993)
  • K931866 — SITE'S CD II PHACOEMULSIFICATION HANDPIECE (November 12, 1993)
  • K921135 — IOLAB POWER I.V. POLE (June 3, 1992)
  • K920582 — 180 TIP, 1/A HANDPIECE .3MM END OPENING FOR OPHT. (May 8, 1992)
  • K912902 — PHACOEMULSIFICATION SYSTEM FOR OPHTHALMIC USE (December 17, 1991)
  • K912739 — SITE 90 TIP, I/A HANDPIECE .3MM SIDE OPEN/OPTH USE (August 28, 1991)
  • K910980 — SITE 20 GAUGE REUSABLE FIBER OPTIC CABLE (May 22, 1991)
  • K904183 — SITE PHACOEMULSIFICATION HANDPIECE (December 5, 1990)
  • K904151 — SITE 19 GAUGE ULTRASONIC I/A PHACO NEEDLE (December 5, 1990)

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