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510(k) K961310

STORZ PREMIERE II MICROSURGICAL SYSTEM (CX SERIES) by Storz Instrument Co. — Product Code HQC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 27, 1996
Date Received
April 4, 1996
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

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  • K960003 — STORZ D7116 MICROVIT VITRECTOMY CUTTER EXTENSION (August 29, 1996)
  • K962131 — STORZ D4600 AIR EXCHANGE LINE PACK (August 23, 1996)
  • K961874 — STORZ DP5100 ANTERIOR COLLECTION CASSETTE PACK (August 6, 1996)

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