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510(k) K834540

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

K834540 is an FDA 510(k) premarket notification submitted by Imm Enterprises , Ltd. for the device "OP-CON SURGICAL INSTRUMENT #9". The FDA issued a decision of Substantially Equivalent on March 6, 1984. The device falls under product code KBN (Gag, Mouth), a Class I device regulated under 21 CFR 874.4420. Imm Enterprises , Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 6, 1984
Date Received
December 1, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Gag, Mouth
Device Class
Class I
Regulation Number
874.4420
Review Panel
EN
Submission Type

Other clearances by Imm Enterprises , Ltd.

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

Other clearances for product code KBN

  • K822183 — MOUTH GAGS (August 16, 1982)
  • K780992 — MILLARD MOUTH GAG (August 17, 1978)

FDA data resources