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510(k) K904699

COMPAC(TM) DIODE LASERS by Hgm Medical Laser Systems, Inc. — Product Code HQF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 25, 1991
Date Received
October 16, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Laser, Ophthalmic
Device Class
Class II
Regulation Number
886.4390
Review Panel
OP
Submission Type

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  • K911104 — PHOTCOAGULATOR KR-568 LASER SPECTRUM ELITE K1 (June 11, 1991)
  • K910898 — SURGICA(TM) H (May 31, 1991)
  • K904700 — ENDOCOAGULATOR KRS568(TM) LASER (February 19, 1991)

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