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510(k) K020824

SPEEDBAND SUPERVIEW SUPER 7, INJECTION SPEEDBAND SUPERVIEW SUPER 7, MODELS 4205 AND 4238 by Boston Scientific Corp — Product Code FHN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 12, 2002
Date Received
March 14, 2002
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ligator, Hemorrhoidal
Device Class
Class II
Regulation Number
876.4400
Review Panel
GU
Submission Type

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  • K091519 — HAEMOBAND MULTI-LIGATOR (July 28, 2009)
  • K070881 — LEM HEMORRHOIDAL LIGATOR, MODELS A.5650, A.5660 (September 26, 2007)
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  • K001236 — RIZA BAND STRETCHER (RBS)-60000 (July 17, 2000)
  • K000297 — ERCHINGER HEMORRHOIDAL LIGATORS: SUCTION LIGATORS, MOD. ERCHINGER, RUDD, MCGIVNE (April 24, 2000)