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510(k) K883506

IRRIGATION KIT by L H M Ent., Inc. — Product Code KYZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 13, 1988
Date Received
August 17, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Syringe, Irrigating (Non Dental)
Device Class
Class I
Regulation Number
880.6960
Review Panel
HO
Submission Type

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  • K894610 — CUSTOM TRAYS, KITS (March 15, 1990)
  • K900439 — SINGLE-USE, STERILE, PREFILLED SYRINGE, 60CC (February 15, 1990)
  • K894611 — CATHETER CARE KITS (December 15, 1989)

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