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510(k) K840313

CAT. 9 ANESTHESIOLOGY RESPIRATORY DEV by Imm Enterprises , Ltd. — Product Code BWB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 4, 1984
Date Received
January 24, 1984
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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  • K840318 — CAT. 14-CLINICAL TOXIOLOGY DEVICES (April 23, 1984)
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  • K834171 — OP-CON SURG. INSTRUMENT #3 (April 4, 1984)
  • K834191 — JAKOBI SURGICAL INSTRUMENTS #3 17/18/19 (March 22, 1984)
  • K834192 — JAKOBI SURG. INSTRUMENTS #3 21/22/24 (March 22, 1984)

Other clearances for product code BWB

  • K884584 — TONGUE SEIZING FORCEPS WITH & WITHOUT RUBBER PADS (November 14, 1988)
  • K880318 — ROVENSTEIN FORCEPS (March 21, 1988)
  • K880319 — MAGILL FORCEPS (March 21, 1988)
  • K834169 — OP-CON SURGICAL INSTRUMENT #9 (January 17, 1984)
  • K820451 — INTRODUCER FOR ENDOTRACHEAL TUBE (March 26, 1982)