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510(k) K860014

SYSTEMS PLUS by United Surgical Corp. — Product Code HQE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 5, 1986
Date Received
January 3, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instrument, Vitreous Aspiration And Cutting, Ac-Powered
Device Class
Class II
Regulation Number
886.4150
Review Panel
OP
Submission Type

Other clearances by United Surgical Corp.

  • K902150 — PIEZO HANDPIECE (July 5, 1990)
  • K870671 — PHACOTRON DAY PAK (April 6, 1987)
  • K870806 — NON-STERILE, EXTRA PLUS PAK CAT. #USPK 2100 (March 26, 1987)
  • K870195 — UNITED SURGICAL CORP. CRYOPTIC PLUS (February 20, 1987)
  • K870194 — UNITED SURGICAL CORP. DIATHERMIC PLUS (February 20, 1987)
  • K830741 — PARAMETRIC STERILITY RELEASE OF AUTO (August 11, 1983)

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  • K102222 — ULTIMATE VIT ENHAMCER (UVE) (April 8, 2011)
  • K033390 — COLIBRI DISPOSABLE VITRECTOMY CUTTER (November 4, 2003)
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  • K023939 — VELOCITY ADVANTAGE (April 17, 2003)