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510(k) K983374

AGATHA-A-H2010 by Midian Intl. — Product Code EFS

K983374 is an FDA 510(k) premarket notification submitted by Midian Intl. for the device "AGATHA-A-H2010". The FDA issued a decision of Substantially Equivalent on December 23, 1998. The device falls under product code EFS (Unit, Oral Irrigation), a Class I device regulated under 21 CFR 872.6510.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 23, 1998
Date Received
September 25, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Unit, Oral Irrigation
Device Class
Class I
Regulation Number
872.6510
Review Panel
DE
Submission Type

Other clearances for product code EFS

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  • K001493 — DENTAL AIR FORCE HOME DENTAL CLEANING SYSTEM, MODEL NO. 0020001 (October 25, 2000)
  • K964810 — DERMADAM (February 10, 1997)
  • K952234 — BARRIER ALL FILM (July 31, 1995)
  • K943182 — ORAL-B PERIOFLEX SUBGINGIVAL IRRIGATOR (September 9, 1994)
  • K923711 — PERIOFLEX TIP (May 16, 1994)
  • K923937 — HYDRO FLOSS (February 25, 1994)
  • K931380 — WATER PIK PLUS PLAQUE CONTROL SYSTEM (September 20, 1993)
  • K923457 — SHOWERFLOSS (September 1, 1992)
  • K922307 — SHOWERFLOSS ORAL IRRIGATION UNIT (June 16, 1992)

FDA data resources