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510(k) K833747

GALLIE CRYONUCLEATOR by Mono Research Laboratories — Product Code HPS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 9, 1984
Date Received
October 26, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Unit, Cryophthalmic
Device Class
Class II
Regulation Number
886.4170
Review Panel
OP
Submission Type

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  • K790102 — MODEL 556-01 CRYOEXTRACTOR (February 12, 1979)
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