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510(k) K834169

OP-CON SURGICAL INSTRUMENT #9 by Imm Enterprises , Ltd. — Product Code BWB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 17, 1984
Date Received
November 21, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Forceps, Tube Introduction
Device Class
Class I
Regulation Number
868.5780
Review Panel
AN
Submission Type

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Other clearances for product code BWB

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  • K840313 — CAT. 9 ANESTHESIOLOGY RESPIRATORY DEV (February 4, 1984)
  • K820451 — INTRODUCER FOR ENDOTRACHEAL TUBE (March 26, 1982)