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510(k) K840311

CAT. 7-EAR, NOSE & THROAT DEVICES by Imm Enterprises , Ltd. — Product Code KCP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 9, 1984
Date Received
January 24, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Syringe, Ent
Device Class
Class I
Regulation Number
874.5220
Review Panel
EN
Submission Type

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Other clearances for product code KCP

  • K822754 — EAR/ULCER SYRINGE (October 4, 1982)
  • K810284 — AUTOMATIC TEFLON INJECTION SYRINGE (March 11, 1981)
  • K780599 — SYRINGE, EAR & ULCER (April 19, 1978)