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510(k) K855105

SIMMONS SHELL by Mira, Inc. — Product Code HQT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 31, 1986
Date Received
December 23, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Shell, Scleral
Device Class
Class II
Regulation Number
886.3800
Review Panel
OP
Submission Type

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Other clearances for product code HQT

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