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510(k) K852527

SATALEC SEPTOSONIC SC 80/SC 120 by Spelna, Inc. — Product Code FLG

K852527 is an FDA 510(k) premarket notification submitted by Spelna, Inc. for the device "SATALEC SEPTOSONIC SC 80/SC 120". The FDA issued a decision of Substantially Equivalent on January 3, 1986. The device falls under product code FLG (Cleaner, Ultrasonic, Medical Instrument), a Class I device regulated under 21 CFR 880.6150. Spelna, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 3, 1986
Date Received
June 14, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cleaner, Ultrasonic, Medical Instrument
Device Class
Class I
Regulation Number
880.6150
Review Panel
HO
Submission Type

Other clearances by Spelna, Inc.

  • K852525 — SATALEC PIEZOTEC (January 30, 1986)
  • K852522 — SATALEC SERVOTOME (December 27, 1985)
  • K853200 — 5X2 SATALEC CHIROPODY CASE (October 18, 1985)
  • K852521 — SATLEC PROPHY UNIT PU 3055 (July 31, 1985)
  • K852524 — SATALEC SERVOTORQUE S2 SX2 (July 31, 1985)
  • K832674 — SATELEC PROPHY UNIT PU 2000S (March 16, 1984)
  • K832664 — SATELEC SUPRASSON PIEZOMATIC P2 (March 16, 1984)
  • K832665 — SATELEC SUPRASSON SP 3055 (October 19, 1983)
  • K832673 — SATELEC PROPHY UNIT PU-2000 (October 19, 1983)
  • K820256 — MEDILAC #SR4 & SR 40 (June 25, 1982)

Other clearances for product code FLG

  • K944950 — KLENZYME (December 20, 1994)
  • K944494 — ALSA-KLENZ (October 19, 1994)
  • K944033 — BILL EVANS-KLENZ (October 7, 1994)
  • K941163 — MON-KLENZ (May 18, 1994)
  • K940263 — NPH-KLENZ (May 18, 1994)
  • K935063 — INSTRU KLENZ (May 9, 1994)
  • K934666 — PDS ULTRACLEAN (April 15, 1994)
  • K931270 — SURGICLEAN ENZYMATIC INSTRUMENT CLEANER (April 13, 1994)
  • K933149 — INSTRUMENT DETERGENT CONCENTRATE (February 16, 1994)
  • K884660 — BIOSONIC ULTRASONIC CLEANING SYSTEM (March 16, 1989)

FDA data resources