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510(k) K950125

KARL STORZ BOUGIES AND DILATORS by KARL STORZ Endoscopy-America, Inc. — Product Code FAX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 7, 1995
Date Received
January 12, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bougie, Urological
Device Class
Class I
Regulation Number
876.5520
Review Panel
GU
Submission Type

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Other clearances for product code FAX

  • K822711 — ANTI-MIST, ANTI-FOG EYEGLASS & DENTAL (November 3, 1982)