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510(k) K834184

H.R. JAKOBI SURG. INSTRUMENTS #11 38/67 by Imm Enterprises , Ltd. — Product Code EMF

K834184 is an FDA 510(k) premarket notification submitted by Imm Enterprises , Ltd. for the device "H.R. JAKOBI SURG. INSTRUMENTS #11 38/67". The FDA issued a decision of Substantially Equivalent on Jan 27, 1984. The device falls under product code EMF (Knife, Surgical), a Class I device regulated under 21 CFR 878.4800. Imm Enterprises , Ltd. has 51 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Jan 27, 1984
Date Received
Nov 21, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Knife, Surgical
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
Submission Type
510(k) Exempt

Other clearances by Imm Enterprises , Ltd.

  • K841386 — KOLLMANN URETHRAL DILATOR (May 9, 1984)
  • K840311 — CAT. 7-EAR, NOSE & THROAT DEVICES (May 9, 1984)
  • K841387 — WESTON RECTAL SNARE (May 9, 1984)
  • K840304 — CATEGORY 17-MICROBIOLOGY DEVICES (May 1, 1984)
  • K840318 — CAT. 14-CLINICAL TOXIOLOGY DEVICES (Apr 23, 1984)
  • K840305 — CATEGORY 1 CIRCULATORY SYSTEM DEVICE (Apr 23, 1984)
  • K840312 — CAT. 8 DENTAL DEVICES (Apr 5, 1984)
  • K834171 — OP-CON SURG. INSTRUMENT #3 (Apr 4, 1984)
  • K834191 — JAKOBI SURGICAL INSTRUMENTS #3 17/18/19 (Mar 22, 1984)
  • K834192 — JAKOBI SURG. INSTRUMENTS #3 21/22/24 (Mar 22, 1984)

Other clearances for product code EMF

  • K080133 — MOUNTABLE ENDOSCOPIC BLADE (Mar 13, 2008)
  • K982142 — MOUNTABLE ENDOSCOPIC KNIFE (Dec 30, 1998)
  • K890214 — MICROSURGERY RAZOR BLADE HOLDER (Jan 27, 1989)
  • K890215 — MICROSURGICAL SCARIFIER (Jan 27, 1989)
  • K890217 — MICROSURGICAL KNIVES (Jan 27, 1989)
  • K880094 — VAN-TEC ENDOPYELOTOMY KNIFE (Feb 29, 1988)
  • K863752 — VALTRAC (BAR) REMOVER DEVICE (Oct 24, 1986)
  • K863549 — REUSABLE/DISPOSABLE AUTOPSY KNIFE SET (Sep 30, 1986)
  • K861947 — SURGICAL KNIFE (Jun 6, 1986)
  • K854891 — KNIFE (May 2, 1986)

FDA data resources