Home / 510(k) Clearances / K970249

510(k) K970249

SIMPLEX AIRBRATOR by Simplex Medical Systems, Inc. — Product Code KOJ

K970249 is an FDA 510(k) premarket notification submitted by Simplex Medical Systems, Inc. for the device "SIMPLEX AIRBRATOR". The FDA issued a decision of Substantially Equivalent on May 7, 1997. The device falls under product code KOJ (Airbrush), a Class II device regulated under 21 CFR 872.6080. Simplex Medical Systems, Inc. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 7, 1997
Date Received
January 22, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Airbrush
Device Class
Class II
Regulation Number
872.6080
Review Panel
DE
Submission Type

Other clearances by Simplex Medical Systems, Inc.

  • K932288 — NEONATAL BREATHING CIRCUIT MODIFICATION (December 30, 1994)
  • K904396 — SIMPLEX NEONATAL BREATHING CIRCUIT SYSTEM (March 5, 1991)

Other clearances for product code KOJ

  • K251425 — turbodent touch (May 9, 2025)
  • K063236 — BETA-POWDER (February 16, 2007)
  • K042872 — RONDOFLEX PLUS 360 (November 23, 2004)
  • K033675 — PROSMILE AIR POLISHER AND PROPHYLAXIS POWDER (January 15, 2004)
  • K033215 — PREPAIR (January 9, 2004)
  • K024105 — VELOPEX AQUACUT FLUID ABRASION UNIT (October 9, 2003)
  • K030292 — GROMAN PREPMASTER (April 15, 2003)
  • K021450 — CLINPRO PROPHY POWDER (August 1, 2002)
  • K014188 — NEW PROPHY POWDER (March 15, 2002)
  • K014252 — JETSTREAM (February 19, 2002)

FDA data resources