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510(k) K850572

HGM, INC. MEDICAL LASER ENDOCOAGULATOR MODEL 8-K by Hgm, Inc. — Product Code HQF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 23, 1985
Date Received
February 13, 1985
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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  • K925663 — HGM ASPIRATING ENDOOCULAR(TM) PROBE (August 17, 1993)
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  • K880908 — MODEL PC ARGON LASER (May 3, 1988)
  • K873773 — ENDOCOAGULATOR MODELS 8 AND 20 ARGON LASER (October 13, 1987)
  • K872630 — ENDOCOAGULATOR(TM) MODEL 20 ARGON LASER FOR UROLO. (August 25, 1987)

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