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510(k) K945209

PROCTOSCOPEA & ACCESSORIES, SIGMOIDOSCOPES & ACCESSORIES, PROCTOLOGY INSTRUMENTS by KARL STORZ Endoscopy-America, Inc. — Product Code GCF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 6, 1995
Date Received
October 25, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Proctoscope
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
Submission Type

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Other clearances for product code GCF

  • K790856 — PROCTOSCOPE #501 (May 29, 1979)