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510(k) K954614

EOS BRAND DISPOSABLE PROCTOSCOPE by North Eos Industries, Inc. — Product Code GCP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 10, 1996
Date Received
October 5, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Endoscope, Ac-Powered And Accessories
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
Submission Type

Other clearances by North Eos Industries, Inc.

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  • K860103 — MOD. ENDOPORT SINGLE-USE TROCAR AND SLEEVE (February 12, 1986)
  • K843683 — MODULAR FIBERSCOPE SYSTEM (January 18, 1985)
  • K833859 — TAMPONADE BALLOON CUFF (January 3, 1984)
  • K821999 — ENDOSCOPIC SCLEROTHERAPY BALLOON (August 27, 1982)
  • K801247 — CCD ENDOSCOPE AND ATTACHMENTS (July 28, 1980)
  • K790071 — ENDOSCOPE AND ACCESSORIES (April 2, 1979)
  • K771920 — FIBER OPTICS PROCTOSCOPE (October 20, 1977)