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510(k) K852521

SATLEC PROPHY UNIT PU 3055 by Spelna, Inc. — Product Code KOJ

K852521 is an FDA 510(k) premarket notification submitted by Spelna, Inc. for the device "SATLEC PROPHY UNIT PU 3055". The FDA issued a decision of Substantially Equivalent on July 31, 1985. The device falls under product code KOJ (Airbrush), a Class II device regulated under 21 CFR 872.6080. Spelna, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 31, 1985
Date Received
June 14, 1985
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 Spelna, Inc.

  • K852525 — SATALEC PIEZOTEC (January 30, 1986)
  • K852527 — SATALEC SEPTOSONIC SC 80/SC 120 (January 3, 1986)
  • K852522 — SATALEC SERVOTOME (December 27, 1985)
  • K853200 — 5X2 SATALEC CHIROPODY CASE (October 18, 1985)
  • K852524 — SATALEC SERVOTORQUE S2 SX2 (July 31, 1985)
  • K832664 — SATELEC SUPRASSON PIEZOMATIC P2 (March 16, 1984)
  • K832674 — SATELEC PROPHY UNIT PU 2000S (March 16, 1984)
  • K832673 — SATELEC PROPHY UNIT PU-2000 (October 19, 1983)
  • K832665 — SATELEC SUPRASSON SP 3055 (October 19, 1983)
  • K820256 — MEDILAC #SR4 & SR 40 (June 25, 1982)

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