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510(k) K911104

PHOTCOAGULATOR KR-568 LASER SPECTRUM ELITE K1 by Hgm Medical Laser Systems, Inc. — Product Code FEX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 11, 1991
Date Received
March 13, 1991
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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Other clearances for product code FEX

  • K771725 — BIOSP. TOTAL OSSICULAR REPLACE. PROSTHE. (September 26, 1977)