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510(k) K883480

MODIFIED SITE FIBER OPTIC MODULE FOR OPHTHAL. USE by Site Microsurgical Systems, Inc. — Product Code FCT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 24, 1988
Date Received
August 16, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Headlight, Fiberoptic Focusing
Device Class
Class II
Regulation Number
886.4335
Review Panel
OP
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)
  • K905620 — MODIFIED SITE PERISTALTIC FOOTSWITCH (February 27, 1991)
  • K904183 — SITE PHACOEMULSIFICATION HANDPIECE (December 5, 1990)

Other clearances for product code FCT

  • K960767 — LIGHT COMMANDER (August 26, 1996)
  • K924198 — MODIFIED SITE FIBER OPTIC MODULE (November 23, 1992)
  • K802770 — FIBER OPTIC HEADLIGHT #60-0766766 (December 11, 1980)
  • K802769 — FIBER OPTIC HEADLIGHT #60-0765 (December 11, 1980)
  • K780433 — FIBER OPTIC ADJUSTABLE HEADLIGHT (June 13, 1978)