DETACHABLE SILICONE BALLOON (DSB)— 510(k) K964488

Name: FDA 510(k) clearance K964488
Creator: U.S. Food and Drug Administration
Published: 1998-04-21

Substantially Equivalent

Target Therapeutics

FDA 510(k) clearance K964488 for DETACHABLE SILICONE BALLOON (DSB), Substantially Equivalent on 1998-04-21. Applicant: Target Therapeutics. Device class: 2.

Clearance details

Applicant: Target Therapeutics
Product code: Code MZQ
Device class: Class 2
Regulation: 21 CFR 882.5950
Advisory panel: Neurology
Date received: 1996-11-08
Decision date: 1998-04-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Freemont, CA, US

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Recent devices under product code MZQ

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K965071 — DETACHABLE SLICONE BALLOON (DSB)1998-04-21

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K965189 — SPINNAKER1997-03-24
K964112 — BERENSTEIN COIL1997-02-26
K963307 — GDC PATIENT RETURN ELECTTRODE MODEL 450211996-12-17

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