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510(k) K771725

BIOSP. TOTAL OSSICULAR REPLACE. PROSTHE. by Xomed, Inc. — Product Code FEX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 26, 1977
Date Received
September 13, 1977
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instrument, Catheter, Punch
Device Class
Class I
Regulation Number
876.5090
Review Panel
GU
Submission Type

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  • K993582 — MODIFICATION TO LASER-SHIELD II (January 20, 2000)
  • K993655 — MICRO-FRANCE ELECTROSURGICAL INSTRUMENTS, VARIOUS (December 21, 1999)

Other clearances for product code FEX

  • K911104 — PHOTCOAGULATOR KR-568 LASER SPECTRUM ELITE K1 (June 11, 1991)