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510(k) K834189

JAKOBI SURG. INSTRUMENTS #7 44/47 by Imm Enterprises , Ltd. — Product Code EPY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 6, 1984
Date Received
November 21, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Speculum, Ent
Device Class
Class I
Regulation Number
878.1800
Review Panel
SU
Submission Type

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