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510(k) K923630

PHACO NEEDLES 1000-R & 1000-O NEEDLES by O.R. Specialties, Inc. — Product Code HQC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 6, 1994
Date Received
July 21, 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 O.R. Specialties, Inc.

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  • K923774 — DISPOSABLE ENDOILLUMINATOR (October 19, 1992)
  • K922355 — POLLY'S VITREOUS SCISSORS J-225-S (August 18, 1992)
  • K922180 — LEWICKY O.R.S. TUBING (July 2, 1992)
  • K914038 — POLLY'S CUTTER J-225 (December 9, 1991)
  • K911932 — J105 JAMES SURGICAL SYSTEM I/A PACK (August 26, 1991)
  • K890195 — JAMES SURGICAL SYSTEM J1000 (August 3, 1989)
  • K891161 — VITRECTOMY PACK #J120 (May 26, 1989)

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