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510(k) K834177

H.R. JAKOBI SURG. INSTRUMENTS #4 30/31 by Imm Enterprises , Ltd. — Product Code HGE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 27, 1983
Date Received
November 21, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Amniotome
Device Class
Class I
Regulation Number
884.4530
Review Panel
OB
Submission Type

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  • K834191 — JAKOBI SURGICAL INSTRUMENTS #3 17/18/19 (March 22, 1984)
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Other clearances for product code HGE

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  • K871087 — S.C.M.T. PERFORATOR (March 23, 1987)
  • K850758 — AMNIGLOVE & AMNICOT (April 15, 1985)