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510(k) K926349

PROBLOC INSULATED NEEDLES by Life-Tech Intl., Inc. — Product Code GXZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 29, 1993
Date Received
December 17, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrode, Needle
Device Class
Class II
Regulation Number
882.1350
Review Panel
NE
Submission Type

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  • K953451 — UROPUMP TUBE & DAMPING CHAMGER (October 5, 1995)
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  • K946108 — EAR-A-GATOR (June 13, 1995)
  • K913601 — MICROPHOR (July 15, 1994)
  • K940203 — TRIPLE LUMEN URODYNAMIC CATHETER WITH RADIOPAQUE MARKERS (March 30, 1994)

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