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510(k) K972693

DEROYAL INDUSTRIES, INC. SURGICAL EYE SPEAR by Deroyal Industries, Inc. — Product Code HOZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 30, 1997
Date Received
July 18, 1997
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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