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510(k) K961874

STORZ DP5100 ANTERIOR COLLECTION CASSETTE PACK by Storz Instrument Co. — Product Code HQC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 6, 1996
Date Received
May 15, 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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  • K960024 — STORZ D7120 PHACO HANDPIECE MAINTENANCE KIT & STORZ D7125 PHACO HANDPIECE NEEDLE (September 20, 1996)
  • K960061 — STORZ D7108 MICROSCISSORS HANDPIECE/STORZ D7106 MICROSCISSORS DRIVE TUBE (September 18, 1996)
  • K960003 — STORZ D7116 MICROVIT VITRECTOMY CUTTER EXTENSION (August 29, 1996)
  • K962131 — STORZ D4600 AIR EXCHANGE LINE PACK (August 23, 1996)
  • K961831 — STORZ DP5200 IRRIGATION ADDMINISTRATION SET PACK (August 6, 1996)

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