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510(k) K834173

OP-CON SURGICAL INSTRUMENTS #4 by Imm Enterprises , Ltd. — Product Code LBX

K834173 is an FDA 510(k) premarket notification submitted by Imm Enterprises , Ltd. for the device "OP-CON SURGICAL INSTRUMENTS #4". The FDA issued a decision of Substantially Equivalent on December 27, 1983. The device falls under product code LBX (Pelvimeter, Internal), a Class II device regulated under 21 CFR 884.4530. Imm Enterprises , Ltd. has at least 10 other 510(k) clearances on record.

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
Pelvimeter, Internal
Device Class
Class II
Regulation Number
884.4530
Review Panel
OB
Submission Type

Other clearances by Imm Enterprises , Ltd.

  • K840311 — CAT. 7-EAR, NOSE & THROAT DEVICES (May 9, 1984)
  • K841387 — WESTON RECTAL SNARE (May 9, 1984)
  • K841386 — KOLLMANN URETHRAL DILATOR (May 9, 1984)
  • K840304 — CATEGORY 17-MICROBIOLOGY DEVICES (May 1, 1984)
  • K840318 — CAT. 14-CLINICAL TOXIOLOGY DEVICES (April 23, 1984)
  • K840305 — CATEGORY 1 CIRCULATORY SYSTEM DEVICE (April 23, 1984)
  • K840312 — CAT. 8 DENTAL DEVICES (April 5, 1984)
  • 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)

FDA data resources