Home / 510(k) Clearances / K933149

510(k) K933149

INSTRUMENT DETERGENT CONCENTRATE by Nobelpharma USA, Inc. — Product Code FLG

K933149 is an FDA 510(k) premarket notification submitted by Nobelpharma USA, Inc. for the device "INSTRUMENT DETERGENT CONCENTRATE". The FDA issued a decision of Substantially Equivalent on February 16, 1994. The device falls under product code FLG (Cleaner, Ultrasonic, Medical Instrument), a Class I device regulated under 21 CFR 880.6150. Nobelpharma USA, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 16, 1994
Date Received
June 29, 1993
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 Nobelpharma USA, Inc.

  • K984162 — BRANEMARK BONE-ANCHORED HEARING AID (BAHA) SYSTEM FOR PEDIATRIC USE (June 28, 1999)
  • K962403 — NOBLEPHARMA WIDE ACCESSORIES (September 6, 1996)
  • K955713 — NOBELPHARMA BONE ANCHORED HEARING AID (August 9, 1996)
  • K962130 — BRANEMARK SYSTEMS MKII SELK-TAPPING FIXTURE (July 22, 1996)
  • K961736 — 17 ANGULATED ABUTMENT (July 18, 1996)
  • K961728 — MIRUSCONE ABUTMENT SYSTEM (July 10, 1996)
  • K961737 — CERA ONE ABUTMENT SYSTEM (July 10, 1996)
  • K960639 — ABUTMENT SELECTION KIT (May 14, 1996)
  • K955697 — ABUTMENT RETRIEVAL KIT (January 30, 1996)
  • K955372 — BALL ATTACHMENT SYSTEM (January 23, 1996)

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)
  • K884660 — BIOSONIC ULTRASONIC CLEANING SYSTEM (March 16, 1989)
  • K862282 — RAPIDEX BIOLOGICAL SURFACTANT (May 11, 1987)

FDA data resources