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510(k) K834540

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

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

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  • 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)