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510(k) K921135

IOLAB POWER I.V. POLE by Site Microsurgical Systems, Inc. — Product Code HQC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 3, 1992
Date Received
March 10, 1992
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 Site Microsurgical Systems, Inc.

  • K925828 — MODIFIED SITE TXR SYSTEMS (February 16, 1994)
  • K925921 — MODIFIED SITE DISPOSABLE DIAPHRAGM CASSETTE (December 6, 1993)
  • K931866 — SITE'S CD II PHACOEMULSIFICATION HANDPIECE (November 12, 1993)
  • 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)
  • K905620 — MODIFIED SITE PERISTALTIC FOOTSWITCH (February 27, 1991)
  • K904183 — SITE PHACOEMULSIFICATION HANDPIECE (December 5, 1990)
  • K904151 — SITE 19 GAUGE ULTRASONIC I/A PHACO NEEDLE (December 5, 1990)

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