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510(k) K850050

PMS OPHTHALMOLOGY PACK-PMS EYE TRAY/PACK by Professional Medical Services — Product Code HOZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 23, 1985
Date Received
January 8, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Sponge, Ophthalmic
Device Class
Class II
Regulation Number
886.4790
Review Panel
OP
Submission Type

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