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510(k) K952234

BARRIER ALL FILM by Cottrell, Ltd. — Product Code EFS

K952234 is an FDA 510(k) premarket notification submitted by Cottrell, Ltd. for the device "BARRIER ALL FILM". The FDA issued a decision of Substantially Equivalent on July 31, 1995. The device falls under product code EFS (Unit, Oral Irrigation), a Class I device regulated under 21 CFR 872.6510. Cottrell, Ltd. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 31, 1995
Date Received
May 12, 1995
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 by Cottrell, Ltd.

  • K972708 — ENDO-SPOR PLUS / HYPROCIDE (September 13, 1999)
  • K970726 — VAPOCIDE (May 18, 1998)
  • K960089 — PROCHEK G GLUTARALDEHYDE CONCENTRATION LEVEL INDICATOR (April 4, 1996)
  • K952241 — PROTOUCH OVERGLOVE (August 7, 1995)
  • K932922 — PROCIDE 14 N.S., OMNICIDE/LIQUID & PLUS LIQ ACTIVATOR (July 3, 1995)
  • K951983 — IMNI-II (June 20, 1995)
  • K945575 — PRO BARRIER(TM) TUBE SOX(TM) (March 6, 1995)
  • K893802 — PROVIEW SELF-SEALING STERILIZATION POUCH (April 4, 1990)

Other clearances for product code EFS

  • K023232 — SPLATRFREE SWANGLE 360 DISPOSABLE PROPHYLAXIS ANGLE (December 11, 2002)
  • K001493 — DENTAL AIR FORCE HOME DENTAL CLEANING SYSTEM, MODEL NO. 0020001 (October 25, 2000)
  • K983374 — AGATHA-A-H2010 (December 23, 1998)
  • K964810 — DERMADAM (February 10, 1997)
  • 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