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510(k) K903214

OXYGEN, AIR, VACUUM, AND NITROUS COUPLERS by Medical Fittings, Inc. — Product Code EJF

K903214 is an FDA 510(k) premarket notification submitted by Medical Fittings, Inc. for the device "OXYGEN, AIR, VACUUM, AND NITROUS COUPLERS". The FDA issued a decision of Substantially Equivalent on September 5, 1990. The device falls under product code EJF (Bracket, Metal, Orthodontic), a Class I device regulated under 21 CFR 872.5410. Medical Fittings, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 5, 1990
Date Received
July 23, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bracket, Metal, Orthodontic
Device Class
Class I
Regulation Number
872.5410
Review Panel
DE
Submission Type

Other clearances by Medical Fittings, Inc.

  • K931043 — MF OHMEDA STYLE MEDICAL GAS WALL OUTLETS (June 1, 1993)
  • K931033 — MF CHEMETRON STYLE MEDICAL GAS WALL OUTLETS (June 1, 1993)
  • K920360 — TIMOX OXYGEN TIMER (August 3, 1992)
  • K914980 — HEX, QUAD, OR RAIL BLOCK MANIFOLD ACCESSORIES (January 21, 1992)
  • K912763 — OHMEDA STYLE CHECK UNITS (FEMALE COUPLERS) (October 15, 1991)
  • K905091 — VARIOUS MALE QUICK CONNECTS. (March 4, 1991)
  • K905094 — SCHRADER OXYGEN/AIR VAC&NITR-OXIDE MALE QUICK CONN (November 20, 1990)
  • K904701 — MEDI FITT/OHMEDA OXY/AIR/VAC&NIT-OXI MALE QK CONN (October 31, 1990)
  • K904702 — MEDI FITT/OXEQUIP OXYGEN/AIR MALE QUICK CONNECTS (October 31, 1990)
  • K904757 — OXYGEN, AIR, VACUUM & NITROUS-OXIDE COUPLERS (October 31, 1990)

Other clearances for product code EJF

  • K994357 — BITEM LOCK, MODELS SW006, SW012 (March 14, 2000)
  • K932825 — MICROARCH GOLD BRACKET (May 9, 1994)
  • K933501 — ALASTIK (April 28, 1994)
  • K923372 — MEMORY WIRE (April 22, 1994)
  • K933080 — ORTHOTECH DURA-GOLD BARCKETS (March 23, 1994)
  • K935139 — FASCINATION CERAMIC BRACKET (February 4, 1994)
  • K936244 — REGENCY BRACKET (February 2, 1994)
  • K934881 — REFLECTIONS (February 1, 1994)
  • K935122 — DENTAURUM METAL BRACKETS (January 31, 1994)
  • K925028 — FORESTADENT ORTHODONTIC BANDS (January 26, 1994)

FDA data resources