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510(k) K834192

JAKOBI SURG. INSTRUMENTS #3 21/22/24 by Imm Enterprises , Ltd. — Product Code KOA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 22, 1984
Date Received
November 21, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Surgical Instruments, G-U, Manual (And Accessories)
Device Class
Class I
Regulation Number
876.4730
Review Panel
GU
Submission Type

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  • K834171 — OP-CON SURG. INSTRUMENT #3 (April 4, 1984)
  • K834191 — JAKOBI SURGICAL INSTRUMENTS #3 17/18/19 (March 22, 1984)
  • K840310 — CATEGORY 6 OPTHALMIC DEVICES (March 16, 1984)

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